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Siemens Medical Solutions USA, Inc
Siemens Medical Solutions USA, Inc: 796 FDA recall reports
Every medical device recall the FDA has published for Siemens Medical Solutions USA, Inc. The fault, and how the agency graded it.
796Reports
16Class I
154Ongoing
2026-07-08Most recent
16 Class I on this pageClass I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
ARTIS icono ceiling. Model Number: 11328100.
Z-2648-2026 · Class II · reported 2026-07-08 · Ongoing
- Why it was recalled
- Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place. Over time some screws that keep the monitor attached to the suspension may gradually loosen.
- Product
- ARTIS icono ceiling. Model Number: 11328100.
- Where it went
- US Nationwide distribution in the states of CA, GA, IA, IN, LA, MO, NC, NY, PA, SC.
- How much
- 57 units
ARTIS icono floor. Model Number: 11327700.
Z-2643-2026 · Class II · reported 2026-07-08 · Ongoing
- Why it was recalled
- Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
- Product
- ARTIS icono floor. Model Number: 11327700.
- Where it went
- US Nationwide distribution.
- How much
- 30 units
ARTIS icono biplane. Model Number: 11327600.
Z-2641-2026 · Class II · reported 2026-07-08 · Ongoing
- Why it was recalled
- Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
- Product
- ARTIS icono biplane. Model Number: 11327600.
- Where it went
- US Nationwide distribution.
- How much
- 85 units
ARTIS icono ceiling. Model Number: 11328100.
Z-2642-2026 · Class II · reported 2026-07-08 · Ongoing
- Why it was recalled
- Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
- Product
- ARTIS icono ceiling. Model Number: 11328100.
- Where it went
- US Nationwide distribution.
- How much
- 119 units
ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 1132810
Z-2206-2026 · Class II · reported 2026-06-10 · Ongoing
- Why it was recalled
- During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.
- Product
- ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS icono floor Model 11327700. interventional fluoroscopic x-ray system
- Where it went
- US and Worldwide
ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system
Z-2205-2026 · Class II · reported 2026-06-10 · Ongoing
- Why it was recalled
- During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.
- Product
- ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system
- Where it went
- US and Worldwide
ARTIS Pheno VE30A and VE40A, Model 10849000
Z-1814-2026 · Class II · reported 2026-04-22 · Ongoing
- Why it was recalled
- During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. The variation of brightness is a result of a constant unregulated medium dose and the angular change of patient diameter caused by rotational acquisition. This may result in unintentional low-dose radiation exposure to a patient.
- Product
- ARTIS Pheno VE30A and VE40A, Model 10849000
- Where it went
- U.S. and O.U.S.
- How much
- 73
ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.
Z-1653-2026 · Class II · reported 2026-04-15 · Ongoing
- Why it was recalled
- During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. Despite the reported dose showing significantly higher, the actual applied x-ray dose levels are in accordance with the system settings and imaging conditions, as well as the applicable regulatory requirements.
- Product
- ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- U.S. 758, OUS 2077
NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syn
Z-1242-2026 · Class II · reported 2026-02-11 · Ongoing
- Why it was recalled
- To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
- Product
- NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
- Where it went
- Worldwide distribution - US Nationwide and the countries of Canada, Costa Rica, India, Israel.
- How much
- 2 units
SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.
Z-1239-2026 · Class II · reported 2026-02-11 · Ongoing
- Why it was recalled
- To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
- Product
- SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
- Where it went
- Worldwide distribution - US Nationwide and the countries of Canada, Costa Rica, India, Israel.
- How much
- 2 units
NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.C
Z-1240-2026 · Class II · reported 2026-02-11 · Ongoing
- Why it was recalled
- To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
- Product
- NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
- Where it went
- Worldwide distribution - US Nationwide and the countries of Canada, Costa Rica, India, Israel.
- How much
- 88 units
NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities s
Z-1241-2026 · Class II · reported 2026-02-11 · Ongoing
- Why it was recalled
- To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
- Product
- NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
- Where it went
- Worldwide distribution - US Nationwide and the countries of Canada, Costa Rica, India, Israel.
- How much
- 5 units
Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With S
Z-1174-2026 · Class II · reported 2026-02-04 · Ongoing
- Why it was recalled
- Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed.
- Product
- Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02
- Where it went
- Worldwide - US Nationwide distribution in the states of AK, CA, IL, MN, NY, OR, VA, WI and the countries of Austria, Belgium, Denmark, France, Germany, Greece, Ireland, Italy, Netherlands, Norway, South Africa, Spain, Sweden, Switzerland.
- How much
- 41 units
Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Material Number (SMN): 11574003; With S
Z-1175-2026 · Class II · reported 2026-02-04 · Ongoing
- Why it was recalled
- Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed.
- Product
- Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Material Number (SMN): 11574003; With Software Version VB10D-SP02
- Where it went
- Worldwide - US Nationwide distribution in the states of AK, CA, IL, MN, NY, OR, VA, WI and the countries of Austria, Belgium, Denmark, France, Germany, Greece, Ireland, Italy, Netherlands, Norway, South Africa, Spain, Sweden, Switzerland.
- How much
- 7 units
LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
Z-0999-2026 · Class II · reported 2026-01-14 · Ongoing
- Why it was recalled
- A potential issue associated with LUMINOS Lotus Max and Luminos dRF Max systems with software version VF11 with bucky wall stand for mobile detectors and without ceiling stand .When switching quickly between organ programs (OGPs) the collimation may be incorrect.
- Product
- LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
- Where it went
- U.S. and OUS
- How much
- U.S.: 1, OUS: 95
MAMMOMAT Inspiration;
Z-0878-2026 · Class II · reported 2025-12-10 · Ongoing
- Why it was recalled
- There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.
- Product
- MAMMOMAT Inspiration;
- Where it went
- Worldwide - US Nationwide distribution in the states of AR, CA, NY and the countries of Australia, Canada, India.
- How much
- 6 units (3 US, 3 OUS)
MAMMOMAT Fusion;
Z-0879-2026 · Class II · reported 2025-12-10 · Ongoing
- Why it was recalled
- There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.
- Product
- MAMMOMAT Fusion;
- Where it went
- Worldwide - US Nationwide distribution in the states of AR, CA, NY and the countries of Australia, Canada, India.
- How much
- 1 unit (OUS only)
MAMMOMAT Revelation;
Z-0877-2026 · Class II · reported 2025-12-10 · Ongoing
- Why it was recalled
- There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.
- Product
- MAMMOMAT Revelation;
- Where it went
- Worldwide - US Nationwide distribution in the states of AR, CA, NY and the countries of Australia, Canada, India.
- How much
- 7 units (3 US, 4 OUS)
Class I
MAGNETOM Cima.X Upgrade. Model Number: 11689304.
Z-0431-2026 · Class I · reported 2025-11-19 · Ongoing
- Why it was recalled
- There is a potential for an ice blockage to form or currently exist within the primary and/or the auxiliary venting paths of the magnet helium containment venting system. In the event of a quench when both venting paths are blocked, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
- Product
- MAGNETOM Cima.X Upgrade. Model Number: 11689304.
- Where it went
- US distribution to California. International distribution to Australia, Germany, Great Britian.
- How much
- 4 system (1 US; 3 OUS)
Class I
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K
Z-2660-2025 · Class I · reported 2025-10-08 · Ongoing
- Why it was recalled
- There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
- Product
- MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
- Where it went
- Worldwide distribution - US Nationwide and the countries of United Arab Emirates, Armenia, Angola, Argentina, Austria, Australia, Azerbaijan, Bosnia and Herzegovina, Bangladesh, Belgium, Bulgaria, Bahrain, Brunei Darussalam, Brazil, Botswana, Belarus, Canada, Switzerland, Chile, China, Colombia, Cyprus, Czechia, Germany, Denmark, Algeria, Ecuador, Estonia, Egypt, Spain, Ethiopia, Finland, Faroe Islands, France, United Kingdom of Great Britian and Northern Ireland, Georgia, Greece, Hong Kong, Croatia, Hungary, Canary Islands, Indonesia, Ireland, Israel, India, Iran, Iceland, Italy, Jordan, Japan, Kenya, Korea, Kuwait, Kazakhstan, Lebanon, Sri Lanka, Lithuania, Luxembourg, Latvia, Morocco, Monaco, Moldova, Montenegro, Republic of North Macedonia, Myanmar, Mongolia, Macao, Malta, Maldives, Mexico, Malaysia, Mozambique, Nigeria, Netherlands, Norway, Nepal, New Zealand, Oman, Panama, Peru, Philippines, Pakistan, Poland, Portugal, Paraguay, Qatar, Reunion, Romania, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Senegal, Syrian Arab Republic, Thailand, Turkmenistan, Tunisia, Turkey, Trinidad and Tobago, Taiwan, Tanzania, Ukraine, Uganda, Uzbekistan, Viet...
- How much
- 586 units
Class I
Biograph mMR. Model Number: 10433372.
Z-2654-2025 · Class I · reported 2025-10-08 · Ongoing
- Why it was recalled
- There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
- Product
- Biograph mMR. Model Number: 10433372.
- Where it went
- Worldwide distribution - US Nationwide and the countries of United Arab Emirates, Armenia, Angola, Argentina, Austria, Australia, Azerbaijan, Bosnia and Herzegovina, Bangladesh, Belgium, Bulgaria, Bahrain, Brunei Darussalam, Brazil, Botswana, Belarus, Canada, Switzerland, Chile, China, Colombia, Cyprus, Czechia, Germany, Denmark, Algeria, Ecuador, Estonia, Egypt, Spain, Ethiopia, Finland, Faroe Islands, France, United Kingdom of Great Britian and Northern Ireland, Georgia, Greece, Hong Kong, Croatia, Hungary, Canary Islands, Indonesia, Ireland, Israel, India, Iran, Iceland, Italy, Jordan, Japan, Kenya, Korea, Kuwait, Kazakhstan, Lebanon, Sri Lanka, Lithuania, Luxembourg, Latvia, Morocco, Monaco, Moldova, Montenegro, Republic of North Macedonia, Myanmar, Mongolia, Macao, Malta, Maldives, Mexico, Malaysia, Mozambique, Nigeria, Netherlands, Norway, Nepal, New Zealand, Oman, Panama, Peru, Philippines, Pakistan, Poland, Portugal, Paraguay, Qatar, Reunion, Romania, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Senegal, Syrian Arab Republic, Thailand, Turkmenistan, Tunisia, Turkey, Trinidad and Tobago, Taiwan, Tanzania, Ukraine, Uganda, Uzbekistan, Viet...
- How much
- 27 units
Class I
MAGNETOM Verio. Model Number: 10276755.
Z-2664-2025 · Class I · reported 2025-10-08 · Ongoing
- Why it was recalled
- There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
- Product
- MAGNETOM Verio. Model Number: 10276755.
- Where it went
- Worldwide distribution - US Nationwide and the countries of United Arab Emirates, Armenia, Angola, Argentina, Austria, Australia, Azerbaijan, Bosnia and Herzegovina, Bangladesh, Belgium, Bulgaria, Bahrain, Brunei Darussalam, Brazil, Botswana, Belarus, Canada, Switzerland, Chile, China, Colombia, Cyprus, Czechia, Germany, Denmark, Algeria, Ecuador, Estonia, Egypt, Spain, Ethiopia, Finland, Faroe Islands, France, United Kingdom of Great Britian and Northern Ireland, Georgia, Greece, Hong Kong, Croatia, Hungary, Canary Islands, Indonesia, Ireland, Israel, India, Iran, Iceland, Italy, Jordan, Japan, Kenya, Korea, Kuwait, Kazakhstan, Lebanon, Sri Lanka, Lithuania, Luxembourg, Latvia, Morocco, Monaco, Moldova, Montenegro, Republic of North Macedonia, Myanmar, Mongolia, Macao, Malta, Maldives, Mexico, Malaysia, Mozambique, Nigeria, Netherlands, Norway, Nepal, New Zealand, Oman, Panama, Peru, Philippines, Pakistan, Poland, Portugal, Paraguay, Qatar, Reunion, Romania, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Senegal, Syrian Arab Republic, Thailand, Turkmenistan, Tunisia, Turkey, Trinidad and Tobago, Taiwan, Tanzania, Ukraine, Uganda, Uzbekistan, Viet...
- How much
- 154 units
Class I
MAGNETOM Lumina (DE). Model Number: 11344916.
Z-2658-2025 · Class I · reported 2025-10-08 · Ongoing
- Why it was recalled
- There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
- Product
- MAGNETOM Lumina (DE). Model Number: 11344916.
- Where it went
- Worldwide distribution - US Nationwide and the countries of United Arab Emirates, Armenia, Angola, Argentina, Austria, Australia, Azerbaijan, Bosnia and Herzegovina, Bangladesh, Belgium, Bulgaria, Bahrain, Brunei Darussalam, Brazil, Botswana, Belarus, Canada, Switzerland, Chile, China, Colombia, Cyprus, Czechia, Germany, Denmark, Algeria, Ecuador, Estonia, Egypt, Spain, Ethiopia, Finland, Faroe Islands, France, United Kingdom of Great Britian and Northern Ireland, Georgia, Greece, Hong Kong, Croatia, Hungary, Canary Islands, Indonesia, Ireland, Israel, India, Iran, Iceland, Italy, Jordan, Japan, Kenya, Korea, Kuwait, Kazakhstan, Lebanon, Sri Lanka, Lithuania, Luxembourg, Latvia, Morocco, Monaco, Moldova, Montenegro, Republic of North Macedonia, Myanmar, Mongolia, Macao, Malta, Maldives, Mexico, Malaysia, Mozambique, Nigeria, Netherlands, Norway, Nepal, New Zealand, Oman, Panama, Peru, Philippines, Pakistan, Poland, Portugal, Paraguay, Qatar, Reunion, Romania, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Senegal, Syrian Arab Republic, Thailand, Turkmenistan, Tunisia, Turkey, Trinidad and Tobago, Taiwan, Tanzania, Ukraine, Uganda, Uzbekistan, Viet...
- How much
- 130 units
Class I
MAGNETOM Spectra as the following: 1. MAGNETOM Spectra. Model Number: 10837643. 2. MAGNETOM Spectra (CN). M
Z-2663-2025 · Class I · reported 2025-10-08 · Ongoing
- Why it was recalled
- There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
- Product
- MAGNETOM Spectra as the following: 1. MAGNETOM Spectra. Model Number: 10837643. 2. MAGNETOM Spectra (CN). Model Number: 10655588.
- Where it went
- Worldwide distribution - US Nationwide and the countries of United Arab Emirates, Armenia, Angola, Argentina, Austria, Australia, Azerbaijan, Bosnia and Herzegovina, Bangladesh, Belgium, Bulgaria, Bahrain, Brunei Darussalam, Brazil, Botswana, Belarus, Canada, Switzerland, Chile, China, Colombia, Cyprus, Czechia, Germany, Denmark, Algeria, Ecuador, Estonia, Egypt, Spain, Ethiopia, Finland, Faroe Islands, France, United Kingdom of Great Britian and Northern Ireland, Georgia, Greece, Hong Kong, Croatia, Hungary, Canary Islands, Indonesia, Ireland, Israel, India, Iran, Iceland, Italy, Jordan, Japan, Kenya, Korea, Kuwait, Kazakhstan, Lebanon, Sri Lanka, Lithuania, Luxembourg, Latvia, Morocco, Monaco, Moldova, Montenegro, Republic of North Macedonia, Myanmar, Mongolia, Macao, Malta, Maldives, Mexico, Malaysia, Mozambique, Nigeria, Netherlands, Norway, Nepal, New Zealand, Oman, Panama, Peru, Philippines, Pakistan, Poland, Portugal, Paraguay, Qatar, Reunion, Romania, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Senegal, Syrian Arab Republic, Thailand, Turkmenistan, Tunisia, Turkey, Trinidad and Tobago, Taiwan, Tanzania, Ukraine, Uganda, Uzbekistan, Viet...
- How much
- 3 units
Class I
MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.
Z-2662-2025 · Class I · reported 2025-10-08 · Ongoing
- Why it was recalled
- There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
- Product
- MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.
- Where it went
- Worldwide distribution - US Nationwide and the countries of United Arab Emirates, Armenia, Angola, Argentina, Austria, Australia, Azerbaijan, Bosnia and Herzegovina, Bangladesh, Belgium, Bulgaria, Bahrain, Brunei Darussalam, Brazil, Botswana, Belarus, Canada, Switzerland, Chile, China, Colombia, Cyprus, Czechia, Germany, Denmark, Algeria, Ecuador, Estonia, Egypt, Spain, Ethiopia, Finland, Faroe Islands, France, United Kingdom of Great Britian and Northern Ireland, Georgia, Greece, Hong Kong, Croatia, Hungary, Canary Islands, Indonesia, Ireland, Israel, India, Iran, Iceland, Italy, Jordan, Japan, Kenya, Korea, Kuwait, Kazakhstan, Lebanon, Sri Lanka, Lithuania, Luxembourg, Latvia, Morocco, Monaco, Moldova, Montenegro, Republic of North Macedonia, Myanmar, Mongolia, Macao, Malta, Maldives, Mexico, Malaysia, Mozambique, Nigeria, Netherlands, Norway, Nepal, New Zealand, Oman, Panama, Peru, Philippines, Pakistan, Poland, Portugal, Paraguay, Qatar, Reunion, Romania, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Senegal, Syrian Arab Republic, Thailand, Turkmenistan, Tunisia, Turkey, Trinidad and Tobago, Taiwan, Tanzania, Ukraine, Uganda, Uzbekistan, Viet...
- How much
- 39 units
Class I
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443
Z-2667-2025 · Class I · reported 2025-10-08 · Ongoing
- Why it was recalled
- There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
- Product
- MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
- Where it went
- Worldwide distribution - US Nationwide and the countries of United Arab Emirates, Armenia, Angola, Argentina, Austria, Australia, Azerbaijan, Bosnia and Herzegovina, Bangladesh, Belgium, Bulgaria, Bahrain, Brunei Darussalam, Brazil, Botswana, Belarus, Canada, Switzerland, Chile, China, Colombia, Cyprus, Czechia, Germany, Denmark, Algeria, Ecuador, Estonia, Egypt, Spain, Ethiopia, Finland, Faroe Islands, France, United Kingdom of Great Britian and Northern Ireland, Georgia, Greece, Hong Kong, Croatia, Hungary, Canary Islands, Indonesia, Ireland, Israel, India, Iran, Iceland, Italy, Jordan, Japan, Kenya, Korea, Kuwait, Kazakhstan, Lebanon, Sri Lanka, Lithuania, Luxembourg, Latvia, Morocco, Monaco, Moldova, Montenegro, Republic of North Macedonia, Myanmar, Mongolia, Macao, Malta, Maldives, Mexico, Malaysia, Mozambique, Nigeria, Netherlands, Norway, Nepal, New Zealand, Oman, Panama, Peru, Philippines, Pakistan, Poland, Portugal, Paraguay, Qatar, Reunion, Romania, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Senegal, Syrian Arab Republic, Thailand, Turkmenistan, Tunisia, Turkey, Trinidad and Tobago, Taiwan, Tanzania, Ukraine, Uganda, Uzbekistan, Viet...
- How much
- 498 units
Class I
MAGNETOM Vida Fit. Model Number: 11410481.
Z-2668-2025 · Class I · reported 2025-10-08 · Ongoing
- Why it was recalled
- There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
- Product
- MAGNETOM Vida Fit. Model Number: 11410481.
- Where it went
- Worldwide distribution - US Nationwide and the countries of United Arab Emirates, Armenia, Angola, Argentina, Austria, Australia, Azerbaijan, Bosnia and Herzegovina, Bangladesh, Belgium, Bulgaria, Bahrain, Brunei Darussalam, Brazil, Botswana, Belarus, Canada, Switzerland, Chile, China, Colombia, Cyprus, Czechia, Germany, Denmark, Algeria, Ecuador, Estonia, Egypt, Spain, Ethiopia, Finland, Faroe Islands, France, United Kingdom of Great Britian and Northern Ireland, Georgia, Greece, Hong Kong, Croatia, Hungary, Canary Islands, Indonesia, Ireland, Israel, India, Iran, Iceland, Italy, Jordan, Japan, Kenya, Korea, Kuwait, Kazakhstan, Lebanon, Sri Lanka, Lithuania, Luxembourg, Latvia, Morocco, Monaco, Moldova, Montenegro, Republic of North Macedonia, Myanmar, Mongolia, Macao, Malta, Maldives, Mexico, Malaysia, Mozambique, Nigeria, Netherlands, Norway, Nepal, New Zealand, Oman, Panama, Peru, Philippines, Pakistan, Poland, Portugal, Paraguay, Qatar, Reunion, Romania, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Senegal, Syrian Arab Republic, Thailand, Turkmenistan, Tunisia, Turkey, Trinidad and Tobago, Taiwan, Tanzania, Ukraine, Uganda, Uzbekistan, Viet...
- How much
- 41 units
Class I
MAGNETOM Skyra fit. Model Number: 10849580.
Z-2661-2025 · Class I · reported 2025-10-08 · Ongoing
- Why it was recalled
- There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
- Product
- MAGNETOM Skyra fit. Model Number: 10849580.
- Where it went
- Worldwide distribution - US Nationwide and the countries of United Arab Emirates, Armenia, Angola, Argentina, Austria, Australia, Azerbaijan, Bosnia and Herzegovina, Bangladesh, Belgium, Bulgaria, Bahrain, Brunei Darussalam, Brazil, Botswana, Belarus, Canada, Switzerland, Chile, China, Colombia, Cyprus, Czechia, Germany, Denmark, Algeria, Ecuador, Estonia, Egypt, Spain, Ethiopia, Finland, Faroe Islands, France, United Kingdom of Great Britian and Northern Ireland, Georgia, Greece, Hong Kong, Croatia, Hungary, Canary Islands, Indonesia, Ireland, Israel, India, Iran, Iceland, Italy, Jordan, Japan, Kenya, Korea, Kuwait, Kazakhstan, Lebanon, Sri Lanka, Lithuania, Luxembourg, Latvia, Morocco, Monaco, Moldova, Montenegro, Republic of North Macedonia, Myanmar, Mongolia, Macao, Malta, Maldives, Mexico, Malaysia, Mozambique, Nigeria, Netherlands, Norway, Nepal, New Zealand, Oman, Panama, Peru, Philippines, Pakistan, Poland, Portugal, Paraguay, Qatar, Reunion, Romania, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Senegal, Syrian Arab Republic, Thailand, Turkmenistan, Tunisia, Turkey, Trinidad and Tobago, Taiwan, Tanzania, Ukraine, Uganda, Uzbekistan, Viet...
- How much
- 56 units
Class I
MAGNETOM Cima.X (DE). Model Number: 11647158.
Z-2656-2025 · Class I · reported 2025-10-08 · Ongoing
- Why it was recalled
- There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
- Product
- MAGNETOM Cima.X (DE). Model Number: 11647158.
- Where it went
- Worldwide distribution - US Nationwide and the countries of United Arab Emirates, Armenia, Angola, Argentina, Austria, Australia, Azerbaijan, Bosnia and Herzegovina, Bangladesh, Belgium, Bulgaria, Bahrain, Brunei Darussalam, Brazil, Botswana, Belarus, Canada, Switzerland, Chile, China, Colombia, Cyprus, Czechia, Germany, Denmark, Algeria, Ecuador, Estonia, Egypt, Spain, Ethiopia, Finland, Faroe Islands, France, United Kingdom of Great Britian and Northern Ireland, Georgia, Greece, Hong Kong, Croatia, Hungary, Canary Islands, Indonesia, Ireland, Israel, India, Iran, Iceland, Italy, Jordan, Japan, Kenya, Korea, Kuwait, Kazakhstan, Lebanon, Sri Lanka, Lithuania, Luxembourg, Latvia, Morocco, Monaco, Moldova, Montenegro, Republic of North Macedonia, Myanmar, Mongolia, Macao, Malta, Maldives, Mexico, Malaysia, Mozambique, Nigeria, Netherlands, Norway, Nepal, New Zealand, Oman, Panama, Peru, Philippines, Pakistan, Poland, Portugal, Paraguay, Qatar, Reunion, Romania, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Senegal, Syrian Arab Republic, Thailand, Turkmenistan, Tunisia, Turkey, Trinidad and Tobago, Taiwan, Tanzania, Ukraine, Uganda, Uzbekistan, Viet...
- How much
- 22 units
Class I
MAGNETOM Verio Dot Upgrade. Model Number: 10684334.
Z-2666-2025 · Class I · reported 2025-10-08 · Ongoing
- Why it was recalled
- There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
- Product
- MAGNETOM Verio Dot Upgrade. Model Number: 10684334.
- Where it went
- Worldwide distribution - US Nationwide and the countries of United Arab Emirates, Armenia, Angola, Argentina, Austria, Australia, Azerbaijan, Bosnia and Herzegovina, Bangladesh, Belgium, Bulgaria, Bahrain, Brunei Darussalam, Brazil, Botswana, Belarus, Canada, Switzerland, Chile, China, Colombia, Cyprus, Czechia, Germany, Denmark, Algeria, Ecuador, Estonia, Egypt, Spain, Ethiopia, Finland, Faroe Islands, France, United Kingdom of Great Britian and Northern Ireland, Georgia, Greece, Hong Kong, Croatia, Hungary, Canary Islands, Indonesia, Ireland, Israel, India, Iran, Iceland, Italy, Jordan, Japan, Kenya, Korea, Kuwait, Kazakhstan, Lebanon, Sri Lanka, Lithuania, Luxembourg, Latvia, Morocco, Monaco, Moldova, Montenegro, Republic of North Macedonia, Myanmar, Mongolia, Macao, Malta, Maldives, Mexico, Malaysia, Mozambique, Nigeria, Netherlands, Norway, Nepal, New Zealand, Oman, Panama, Peru, Philippines, Pakistan, Poland, Portugal, Paraguay, Qatar, Reunion, Romania, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Senegal, Syrian Arab Republic, Thailand, Turkmenistan, Tunisia, Turkey, Trinidad and Tobago, Taiwan, Tanzania, Ukraine, Uganda, Uzbekistan, Viet...
- How much
- 78 units
Showing the 30 most recent of 796. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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