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Canon Medical System, USA, INC.
Canon Medical System, USA, INC.: 49 FDA recall reports
Every medical device recall the FDA has published for Canon Medical System, USA, INC.. The fault, and how the agency graded it.
49Reports
0Class I
43Ongoing
2026-02-04Most 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.
Alphenix INFX-8000F, interventional fluoroscopic x-ray system
Z-1177-2026 · Class II · reported 2026-02-04 · Ongoing
- Why it was recalled
- It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed
- Product
- Alphenix INFX-8000F, interventional fluoroscopic x-ray system
- Where it went
- Worldwide distribution - US Nationwide and the country of Dominican Republic.
- How much
- 98 units
Alphenix INFX-8000H, interventional fluoroscopic x-ray system
Z-1178-2026 · Class II · reported 2026-02-04 · Ongoing
- Why it was recalled
- It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed
- Product
- Alphenix INFX-8000H, interventional fluoroscopic x-ray system
- Where it went
- Worldwide distribution - US Nationwide and the country of Dominican Republic.
- How much
- 3 units
Alphenix INFX-8000V, interventional fluoroscopic x-ray system
Z-1179-2026 · Class II · reported 2026-02-04 · Ongoing
- Why it was recalled
- It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed
- Product
- Alphenix INFX-8000V, interventional fluoroscopic x-ray system
- Where it went
- Worldwide distribution - US Nationwide and the country of Dominican Republic.
- How much
- 332 units
Alphenix INFX-8000C, interventional fluoroscopic x-ray system
Z-1176-2026 · Class II · reported 2026-02-04 · Ongoing
- Why it was recalled
- It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed
- Product
- Alphenix INFX-8000C, interventional fluoroscopic x-ray system
- Where it went
- Worldwide distribution - US Nationwide and the country of Dominican Republic.
- How much
- 172 units
VANTAGE GALAN 3T Model MRT-3020/MEXL-3020
Z-1017-2026 · Class II · reported 2026-01-21 · Ongoing
- Why it was recalled
- There is a potential for formation of ice occurring in the venting system of the superconducting magnet of the MRI systems. if a quench occurs in this condition, helium gas may not be able to escape via the designed vent paths, and the pressure in the helium vessel may rise. This pressure build-up could eventually rupture the helium vessel, causing helium gas to be released into the MR scanning room.
- Product
- VANTAGE GALAN 3T Model MRT-3020/MEXL-3020
- Where it went
- U.S. Nationwide distribution in the states of CA, CO, FL, IA, IL, IN, KS, MD, MO, MT, NV, NY, OH, OR, PA, PR, TX, VA, and WI.
- How much
- 34 systems
VANTAGE TITAN 3T Model MRT-3010/MEXL-3010
Z-1018-2026 · Class II · reported 2026-01-21 · Ongoing
- Why it was recalled
- There is a potential for formation of ice occurring in the venting system of the superconducting magnet of the MRI systems. if a quench occurs in this condition, helium gas may not be able to escape via the designed vent paths, and the pressure in the helium vessel may rise. This pressure build-up could eventually rupture the helium vessel, causing helium gas to be released into the MR scanning room.
- Product
- VANTAGE TITAN 3T Model MRT-3010/MEXL-3010
- Where it went
- U.S. Nationwide distribution in the states of CA, CO, FL, IA, IL, IN, KS, MD, MO, MT, NV, NY, OH, OR, PA, PR, TX, VA, and WI.
- How much
- 22 systems
VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.
Z-0327-2026 · Class II · reported 2025-11-05 · Ongoing
- Why it was recalled
- Affected system contains components that do not meet the required distance between electrodes for compliance with the IEC 60601-1 standard for medical electrical equipment.
- Product
- VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.
- Where it went
- US distribution to Ohio and Nevada
- How much
- 2 units
This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography c
Z-0037-2026 · Class II · reported 2025-10-15 · Ongoing
- Why it was recalled
- It has been found that when SPOT Fluoro is first turned on, the default ROI is selected and the collimator blades move to the boundary of the ROI, and the static image is overlayed around the ROI, covering the collimated area. If the customer changes the ROI, the collimator blades and static images are adjusted accordingly. However, when the acquisition program is changed, the collimator returns to the default ROI position which may be larger than the specified one, leaving the X-ray area partially covered by the static image. This is a software problem with the SPOT Fluoro program and will not occur if the function is not used.
- Product
- This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
- Where it went
- U.S.
- How much
- 8
Cartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004, PCD-1000A/3D, is a diagnostic imaging system that co
Z-0284-2025 · Class II · reported 2024-11-13 · Ongoing
- Why it was recalled
- When PET-CT system is executing reconstruction, if PET acquisition for another patient is performed (or PET reconstruction for another patient is performed from raw data processing), PET reconstruction control processing may hang up and PET reconstruction may stop as a result, which may necessitate repeat PET/CT examinations.
- Product
- Cartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004, PCD-1000A/3D, is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
- Where it went
- US: NV, AR, MN, IA, IL, NC, LA, KS, MS, CA, AL, MD, CO, IN, TN, AZ, WI, VA
- How much
- 27
MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-1520), Vantage Titan MRT-1504 (ME
Z-2041-2024 · Class II · reported 2024-06-19 · Ongoing
- Why it was recalled
- The terminal block used to secure the power supply cable for the gradient coil of the MRI system was not secured as designed, which could cause cable disconnection, which could lead to arcing, followed by melting of the cable, ignition, smoke, and fire.
- Product
- MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-1520), Vantage Titan MRT-1504 (MEXL-1504), Vantage Titan 3T MRT-3010 (MEXL-3010), Vantage Galan 3T MRT-3020 (MEXL-3020)
- Where it went
- US: PA, SC, IA, AL, MI, AR, SD, TX, ID, KY, NY, MN, MD, OH, WI, NV, CT, AZ, IL, OK, CA, FL, GA, OR, IN, NJ, CO, MT, KS, MO, WY, VA, VT, LA, NH, WV, TN, PR
- How much
- 153
MRI system: Vantage Elan, Model: MRT-2020
Z-1249-2024 · Class II · reported 2024-03-13 · Ongoing
- Why it was recalled
- For some MRI systems, it has been found that some of the maximum Spatial Field Gradient (SFG) values displayed in "System Information" of the operation window and some of the maximum SFG values described in the safety manual are lower than the correct values, which may cause a patient with an MR conditional device to feel some discomfort during the MR scan.
- Product
- MRI system: Vantage Elan, Model: MRT-2020
- Where it went
- Worldwide - US Nationwide distribution including in the states of MD, IL, WV, CA, AZ, PR, CO, GA, PA, WA, UT, OK, KY, IA, IN, TN, CT, WI, OH, AL, MT, NM, TX, MO, MN, OR, ID, WY, NV, AR, FL, SD, MI, NY, NJ, KS, LA, NH, VT, MS, SC, ME and the country of DO.
- How much
- 1
Vantage Titan, Model: MRT-1504
Z-1250-2024 · Class II · reported 2024-03-13 · Ongoing
- Why it was recalled
- For some MRI systems, it has been found that some of the maximum Spatial Field Gradient (SFG) values displayed in "System Information" of the operation window and some of the maximum SFG values described in the safety manual are lower than the correct values, which may cause a patient with an MR conditional device to feel some discomfort during the MR scan.
- Product
- Vantage Titan, Model: MRT-1504
- Where it went
- Worldwide - US Nationwide distribution including in the states of MD, IL, WV, CA, AZ, PR, CO, GA, PA, WA, UT, OK, KY, IA, IN, TN, CT, WI, OH, AL, MT, NM, TX, MO, MN, OR, ID, WY, NV, AR, FL, SD, MI, NY, NJ, KS, LA, NH, VT, MS, SC, ME and the country of DO.
- How much
- 40
MRI system: Vantage Orian, Vantage Fortian, Model: MRT-1550
Z-1248-2024 · Class II · reported 2024-03-13 · Ongoing
- Why it was recalled
- For some MRI systems, it has been found that some of the maximum Spatial Field Gradient (SFG) values displayed in "System Information" of the operation window and some of the maximum SFG values described in the safety manual are lower than the correct values, which may cause a patient with an MR conditional device to feel some discomfort during the MR scan.
- Product
- MRI system: Vantage Orian, Vantage Fortian, Model: MRT-1550
- Where it went
- Worldwide - US Nationwide distribution including in the states of MD, IL, WV, CA, AZ, PR, CO, GA, PA, WA, UT, OK, KY, IA, IN, TN, CT, WI, OH, AL, MT, NM, TX, MO, MN, OR, ID, WY, NV, AR, FL, SD, MI, NY, NJ, KS, LA, NH, VT, MS, SC, ME and the country of DO.
- How much
- 118
The INFX-8000F is designed to take advantage of the latest technological innovations to reduce dose and to sav
Z-1155-2024 · Class II · reported 2024-02-28 · Ongoing
- Why it was recalled
- VAREX changed the manufacturing of the internal board, and the detectors displayed abnormal images. Internal board of the X-ray flat panel detector may display abnormal images, such as horizontal stripes, which may lead to the inability to complete an ongoing exam, or the patient may need to be examined with another x-ray system.
- Product
- The INFX-8000F is designed to take advantage of the latest technological innovations to reduce dose and to save time. A revolutionary graphic user interface and a multi-tasking computer enable the system to fully meet the requirement for optimum image quality, safety, ease of use, advanced efficiency and improved workflow. The advanced floormounted system INFX-8000F uses a new flat panel detector to present fluoroscopic and fluorographic images of high quality.
- Where it went
- US: CA, LA
- How much
- 2
The device is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an inter
Z-1154-2024 · Class II · reported 2024-02-28 · Ongoing
- Why it was recalled
- VAREX changed the manufacturing of the internal board, and the detectors displayed abnormal images. Internal board of the X-ray flat panel detector may display abnormal images, such as horizontal stripes, which may lead to the inability to complete an ongoing exam, or the patient may need to be examined with another x-ray system.
- Product
- The device is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional setting. The system consists of a C-arm which is equipped with an X-ray tube, beam limiter and X-ray receptor, X-ray controller, computers with system and processing software, and a patient radiographic table.
- Where it went
- US: CA, LA
- How much
- 1
INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE CONSOLE
Z-2392-2023 · Class II · reported 2023-08-16 · Ongoing
- Why it was recalled
- The C-arm, used to set the position and angle of the x-ray exposure field, may not function due to the tableside console PWB, which needs replacement. There may be a delay in the procedure, but procedures can continue using the operators console, the switches on the back of the column, switches on the side of the flat panel detector, and the emergency stop will continue to function normally.
- Product
- INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE CONSOLE
- Where it went
- US Nationwide Distribution: NY, CO, IL, CA, MD, MN, WA
- How much
- 12
Canon Aplio ultrasound system, Model: Aplio i900 TUS-AI900, Aplio i800 TUS-AI800, Aplio i700 TUS-AI700, Aplio
Z-0198-2023 · Class II · reported 2022-11-16 · Ongoing
- Why it was recalled
- After completion, ultrasound system's Stress Echo may not terminate if user does not manually terminate the protocol. During next patient exam, an abnormal confirmation message will be displayed "Same view was saved in this phase. Do you use this image with StressEcho Review?" If "no", acquired images not saved, and if "yes" images assigned to the previous patient; could cause treatment delay.
- Product
- Canon Aplio ultrasound system, Model: Aplio i900 TUS-AI900, Aplio i800 TUS-AI800, Aplio i700 TUS-AI700, Aplio a550 CUS-AA550, Aplio a450 CUS-AA450
- Where it went
- US: MT, MO, NC, SC, MN, WA, KY, TN, AR, IL, IA, MI, WV, KS, CA, HA, CO, LA, OK, ME, KY, NY, PA, GA, FL
- How much
- 65
INFX-8000V. For radiographic and fluoroscopic studies and intervention.
Z-1666-2022 · Class II · reported 2022-09-07 · Ongoing
- Why it was recalled
- The fluoroscopic dose rate might exceed the conforming value during biplane fluoroscopy.
- Product
- INFX-8000V. For radiographic and fluoroscopic studies and intervention.
- Where it went
- US Nationwide Distribution
- How much
- 16 systems
System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: INFX-8000C/BF, INFX-800
Z-1289-2022 · Class II · reported 2022-07-06 · Ongoing
- Why it was recalled
- CT operation may be restricted by an interlock which is a result of an system error and the CT system may stop operating properly after an attempt to cancel the error message has been initiated.
- Product
- System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: INFX-8000C/BF, INFX-8000C/BH, INFX-8000C/SW
- Where it went
- U.S.: CA, CO, FL, NY, and WY O.U.S.: None
- How much
- 6 systems
Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, Item Numbers: INFX-8000V, INFX-80
Z-0492-2022 · Class II · reported 2022-01-19 · Ongoing
- Why it was recalled
- Abnormal images such as horizontal stripes may be displayed and recovery may not not be possible by restarting the system. The worst case scenario is an operator who is working without a workable image may remove a catheter from the patient's blood vessel and damage the blood vessel.
- Product
- Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, Item Numbers: INFX-8000V, INFX-8000C, INFX-8000F, and INFX-8000H.
- Where it went
- US Nationwide distribution in the states of DE, FL, LA, MT, NJ, OH, and WV.
- How much
- 8
Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A
Z-0142-2022 · Class II · reported 2021-10-27 · Terminated
- Why it was recalled
- A software problem has been identified which could result in the diagnostic imaging system not proceeding to the next actual scan even though automatic start of the next scan is specified. This could result in the diagnostic imaging system failing resulting in rescanning and reinjection of contrast medium.
- Product
- Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A
- Where it went
- US Nationwide distribution in the states of NV, AR MN.
- How much
- 3 units
Canon Vantage Titan 3T, Premium Open-Bore MRI System, REF: MRT-3010 - Product Usage: use as a diagnostic imagi
Z-2046-2021 · Class II · reported 2021-07-21 · Ongoing
- Why it was recalled
- The MRI system contains a component that does not meet the appropriate flame retardancy-rating which could result in smoke or fire.
- Product
- Canon Vantage Titan 3T, Premium Open-Bore MRI System, REF: MRT-3010 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.
- Where it went
- US Nationwide distributions in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY.
Toshiba Vantage Tiitan 1.5T with Standard gradient, Premium Open-Bore MRI System, REF: MRT-1504 - Product Usag
Z-2044-2021 · Class II · reported 2021-07-21 · Ongoing
- Why it was recalled
- The MRI system contains a component that does not meet the appropriate flame retardancy-rating which could result in smoke or fire.
- Product
- Toshiba Vantage Tiitan 1.5T with Standard gradient, Premium Open-Bore MRI System, REF: MRT-1504 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.
- Where it went
- US Nationwide distributions in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY.
Canon Vantage Tiitan 1.5T, Premium Open-Bore MRI System, REF: MRT-1510 - Product Usage: use as a diagnostic im
Z-2045-2021 · Class II · reported 2021-07-21 · Ongoing
- Why it was recalled
- The MRI system contains a component that does not meet the appropriate flame retardancy-rating which could result in smoke or fire.
- Product
- Canon Vantage Tiitan 1.5T, Premium Open-Bore MRI System, REF: MRT-1510 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.
- Where it went
- US Nationwide distributions in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY.
Canon Vantage Galan 3T, REF: MRT-3020 - Product Usage: use as a diagnostic imaging modality that produces cros
Z-2047-2021 · Class II · reported 2021-07-21 · Ongoing
- Why it was recalled
- The MRI system contains a component that does not meet the appropriate flame retardancy-rating which could result in smoke or fire.
- Product
- Canon Vantage Galan 3T, REF: MRT-3020 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.
- Where it went
- US Nationwide distributions in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY.
Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000F Catheterization Table CAT-880B Canon CATHETERIZAT
Z-1271-2021 · Class II · reported 2021-03-24 · Ongoing
- Why it was recalled
- System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose.
- Product
- Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000F Catheterization Table CAT-880B Canon CATHETERIZATION TABLE, MODEL CAT-880B INPUT 220V - Product Usage: indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen, and lower extremities.
- Where it went
- Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NJ, NY, OH, OK, PA, SD, TN, TX, WA, WI and WV. The countries of Canada, China, Japan, Korea, and Singapore.
- How much
- Total of all Systems = 145 systems (U.S.)
Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000C Catheterization Table CAT-880B Canon CATHETERIZAT
Z-1270-2021 · Class II · reported 2021-03-24 · Ongoing
- Why it was recalled
- System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose.
- Product
- Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000C Catheterization Table CAT-880B Canon CATHETERIZATION TABLE, MODEL CAT-880B INPUT 220V - Product Usage: indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen, and lower extremities.
- Where it went
- Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NJ, NY, OH, OK, PA, SD, TN, TX, WA, WI and WV. The countries of Canada, China, Japan, Korea, and Singapore.
- How much
- Total of all Systems = 145 systems (U.S.)
Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V Catheterization Table CAT-880B Canon CATHETERIZA
Z-1269-2021 · Class II · reported 2021-03-24 · Ongoing
- Why it was recalled
- System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose.
- Product
- Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V Catheterization Table CAT-880B Canon CATHETERIZATION TABLE, MODEL CAT-880B INPUT 220V - Product Usage: indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen, and lower extremities.
- Where it went
- Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NJ, NY, OH, OK, PA, SD, TN, TX, WA, WI and WV. The countries of Canada, China, Japan, Korea, and Singapore.
- How much
- Total of all Systems = 145 systems (U.S.)
System INFX-8000C
Z-1175-2021 · Class II · reported 2021-03-17 · Ongoing
- Why it was recalled
- The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles.
- Product
- System INFX-8000C
- Where it went
- Nationwide
- How much
- 272 in total
System INFX-8000F
Z-1176-2021 · Class II · reported 2021-03-17 · Ongoing
- Why it was recalled
- The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles.
- Product
- System INFX-8000F
- Where it went
- Nationwide
- How much
- 272 in total
Showing the 30 most recent of 49. 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