thejoe
GE Medical Systems, LLC
GE Medical Systems, LLC: 168 FDA recall reports
Every medical device recall the FDA has published for GE Medical Systems, LLC. The fault, and how the agency graded it.
168Reports
0Class I
124Ongoing
2026-07-22Most recent
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.
Optima XR200amx, Mobile Digital-Ready Radiographic System
Z-2726-2026 · Class II · reported 2026-07-22 · Ongoing
- Why it was recalled
- GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column track. This could result in patient injury during an exam.
- Product
- Optima XR200amx, Mobile Digital-Ready Radiographic System
- Where it went
- Worldwide - US Nationwide and the countries of Brazil, Canada, Korea, Mexico, Saudi Arabia, Spain, UK.
- How much
- 4 units
Optima XR220amx, Mobile Digital-Ready Radiographic System
Z-2727-2026 · Class II · reported 2026-07-22 · Ongoing
- Why it was recalled
- GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column track. This could result in patient injury during an exam.
- Product
- Optima XR220amx, Mobile Digital-Ready Radiographic System
- Where it went
- Worldwide - US Nationwide and the countries of Brazil, Canada, Korea, Mexico, Saudi Arabia, Spain, UK.
- How much
- 38 units
Optima XR240amx, Mobile Digital Radiographic System
Z-2728-2026 · Class II · reported 2026-07-22 · Ongoing
- Why it was recalled
- GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column track. This could result in patient injury during an exam.
- Product
- Optima XR240amx, Mobile Digital Radiographic System
- Where it went
- Worldwide - US Nationwide and the countries of Brazil, Canada, Korea, Mexico, Saudi Arabia, Spain, UK.
- How much
- 24 units
Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-500
Z-2477-2026 · Class II · reported 2026-06-24 · Ongoing
- Why it was recalled
- GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for example, impact during transport, one or more of the fasteners that secure the soffit can disengage. If this occurs, a fastener could fall into the patient compartment. In rare circumstances, if multiple fasteners disengage, the canopy soffit can become loose or detach. These conditions could potentially result in patient injury.
- Product
- Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-500
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 265 units
Giraffe OmniBed, a combination of an infant incubator and an infant warmer, All Models
Z-2475-2026 · Class II · reported 2026-06-24 · Ongoing
- Why it was recalled
- GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for example, impact during transport, one or more of the fasteners that secure the soffit can disengage. If this occurs, a fastener could fall into the patient compartment. In rare circumstances, if multiple fasteners disengage, the canopy soffit can become loose or detach. These conditions could potentially result in patient injury.
- Product
- Giraffe OmniBed, a combination of an infant incubator and an infant warmer, All Models
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 19587 units
Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1, a combination of an infant incubator and an
Z-2476-2026 · Class II · reported 2026-06-24 · Ongoing
- Why it was recalled
- GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for example, impact during transport, one or more of the fasteners that secure the soffit can disengage. If this occurs, a fastener could fall into the patient compartment. In rare circumstances, if multiple fasteners disengage, the canopy soffit can become loose or detach. These conditions could potentially result in patient injury.
- Product
- Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1, a combination of an infant incubator and an infant warmer, Model Numbers 2082844-001-XXX
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 23430 units
Allia IGS 3 Pulse angiographic X-ray system
Z-2314-2026 · Class II · reported 2026-06-17 · Ongoing
- Why it was recalled
- GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.
- Product
- Allia IGS 3 Pulse angiographic X-ray system
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 9 units
Allia IGS Pulse angiographic X-ray system
Z-2317-2026 · Class II · reported 2026-06-17 · Ongoing
- Why it was recalled
- GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.
- Product
- Allia IGS Pulse angiographic X-ray system
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 5 units
Allia Moveo angiographic X-ray system
Z-2318-2026 · Class II · reported 2026-06-17 · Ongoing
- Why it was recalled
- GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.
- Product
- Allia Moveo angiographic X-ray system
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 3 units
Allia IGS 5 Pulse angiographic X-ray system
Z-2315-2026 · Class II · reported 2026-06-17 · Ongoing
- Why it was recalled
- GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.
- Product
- Allia IGS 5 Pulse angiographic X-ray system
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 121 units
Allia IGS 7 Pulse angiographic X-ray system
Z-2316-2026 · Class II · reported 2026-06-17 · Ongoing
- Why it was recalled
- GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.
- Product
- Allia IGS 7 Pulse angiographic X-ray system
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 35 units
Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15
Z-2153-2026 · Class II · reported 2026-05-20 · Ongoing
- Why it was recalled
- GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
- Product
- Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 10 units
Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300
Z-2149-2026 · Class II · reported 2026-05-20 · Ongoing
- Why it was recalled
- GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
- Product
- Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 25 units
Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27
Z-2155-2026 · Class II · reported 2026-05-20 · Ongoing
- Why it was recalled
- GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
- Product
- Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 5 units
Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23
Z-2151-2026 · Class II · reported 2026-05-20 · Ongoing
- Why it was recalled
- GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
- Product
- Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 33 units
Revolution Apex, X-ray Computed Tomography, Model Number 5590000-20
Z-2154-2026 · Class II · reported 2026-05-20 · Ongoing
- Why it was recalled
- GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
- Product
- Revolution Apex, X-ray Computed Tomography, Model Number 5590000-20
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 24 units
Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25
Z-2152-2026 · Class II · reported 2026-05-20 · Ongoing
- Why it was recalled
- GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
- Product
- Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 11 units
Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6
Z-2150-2026 · Class II · reported 2026-05-20 · Ongoing
- Why it was recalled
- GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
- Product
- Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 38 units
Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E8510
Z-1590-2026 · Class II · reported 2026-04-01 · Ongoing
- Why it was recalled
- There is a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position.
- Product
- Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP
- Where it went
- Worldwide distribution - US Nationwide.
- How much
- 125 units
Centricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a device that displays medical images
Z-1570-2026 · Class II · reported 2026-03-25 · Ongoing
- Why it was recalled
- There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data.
- Product
- Centricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 2088026-406, 2100169-001, 2088026-985, 2088026-971, 2088026-614, 2088026-713, 2088026-994, 2100491-006, 2088026-723, 2088026-308, 2104867-044, 2100491-012, 2088026-962, 2088026-969, 2102676-001, 2088026-936, 2088026-960, K1220JWED, 2088026-806, 2088026-506, 2088026-026, 2088026-970, 2088026-943, 2088026-990, 2088026-940, 2088026-959, 2088026-967, 2088026-989, 2104867-045, 2088026-993, 2088026-306, 2102675-010, 2088026-948, 2088026-957, 2088026-973, 2088026-946, 2088026-715, 2088026-906
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 797 units
Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a device that displays medical ima
Z-1571-2026 · Class II · reported 2026-03-25 · Ongoing
- Why it was recalled
- There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data.
- Product
- Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 2088026-026, 2088026-115, 2088026-043, K2042VJED, 2088026-132, 2088026-003, 2088026-110, 2089629-003, 2066908-136, 2066908-150
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 40 units
Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1, a device that displays medical images (
Z-1569-2026 · Class II · reported 2026-03-25 · Ongoing
- Why it was recalled
- There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data.
- Product
- Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 5826659-027, 5826659-029, 5826659-032, 5826659-033, 5826659-028, 5826659-034, 5826659-030, 5826659-019, 5826659-022, 5826659-026, 5826659-023, 5826659-031, 5826659-025, 5826659-002, 5826659-021, 5826659-037, 5826659-014, 5826659-016, 5826659-013
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 1568 units
Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography
Z-0875-2026 · Class II · reported 2025-12-17 · Ongoing
- Why it was recalled
- Some Senographe Pristina systems either have a missing or an incorrect X-Ray Warning label, which is a nonconformance to FDA Regulation 21 CFR ¿1020.30(j).
- Product
- Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography
- Where it went
- U.S. and OUS.
- How much
- 1,818 (1,580 US; 238 OUS)
MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph
Z-0231-2026 · Class II · reported 2025-10-29 · Ongoing
- Why it was recalled
- If a user incorrectly places the Acquisition Module into the Acquisition Module Holder, it can result in excessive bending and wear of the Acquisition Trunk Cable. This is visible as a damaged sheath or exposed wires. If a damaged Acquisition Trunk Cable is not recognized and removed from service, the cable can overheat with continued use.
- Product
- MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Number 2030360-001, Product Codes VU2 and VU4
- Where it went
- Worldwide Distribution: US (nationwide) and OUS (foreign/Global) to countries of: Australia, Austria, Bahrain, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Korea, Republic of, Kuwait, Malaysia, Netherlands, New Zealand, Norway, Philippines, Puerto Rico, Qatar, Saudi Arabia, Singapore, Sweden, Switzerland, Thailand, United Arab Emirates, and United Kingdom.
- How much
- 29,225 units
LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535
Z-0156-2026 · Class II · reported 2025-10-22 · Ongoing
- Why it was recalled
- The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impacting overall care.
- Product
- LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535
- Where it went
- US Nationwide. Global Distribution.
- How much
- 31 units
LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533
Z-0157-2026 · Class II · reported 2025-10-22 · Ongoing
- Why it was recalled
- The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impacting overall care.
- Product
- LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533
- Where it went
- US Nationwide. Global Distribution.
- How much
- 37 units
LOGIQ P10 series with software version R4.5.7 Model Number 5877534
Z-0155-2026 · Class II · reported 2025-10-22 · Ongoing
- Why it was recalled
- The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impacting overall care.
- Product
- LOGIQ P10 series with software version R4.5.7 Model Number 5877534
- Where it went
- US Nationwide. Global Distribution.
- How much
- 65 units
GE HealthCare OEC 9900 Elite C-arm Systems.
Z-2342-2025 · Class II · reported 2025-09-03 · Ongoing
- Why it was recalled
- GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems. Specifically, impacted systems are missing the full layer of lead tape in the collimator covers, which will lead to a small increase in radiation exposure to the patient and/or operator. The missing lead tape is not detectable by the user.
- Product
- GE HealthCare OEC 9900 Elite C-arm Systems.
- Where it went
- US Nationwide distribution.
GE HealthCare OEC 9800.
Z-2341-2025 · Class II · reported 2025-09-03 · Ongoing
- Why it was recalled
- GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems. Specifically, impacted systems are missing the full layer of lead tape in the collimator covers, which will lead to a small increase in radiation exposure to the patient and/or operator. The missing lead tape is not detectable by the user.
- Product
- GE HealthCare OEC 9800.
- Where it went
- US Nationwide distribution.
GE Signa Artist, Nuclear Magnetic Resonance Imaging System
Z-2299-2025 · Class II · reported 2025-08-20 · Ongoing
- Why it was recalled
- GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.
- Product
- GE Signa Artist, Nuclear Magnetic Resonance Imaging System
- Where it went
- Worldwide distribution.
- How much
- 760 units
Showing the 30 most recent of 168. 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.
← All device recalls