Canon Medical System, USA, INC. recalls The INFX-8000F is designed to take advantage of the latest technological innovations to reduce dose and to save time. A…
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…
Read the official notice →- Date
- 2024-02-28
- Country
- United States
- Brand
- Canon Medical System
- Product
- The INFX-8000F is designed to take advantage of the latest technological innovations to reduce dose and to save time. A revolutionary…
- Classification
- Class II
- Units
- US: CA, LA
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Canon Medical System recalls
- 2024-11-13
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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…
FDA · DeviceCanon Medical System, USA, INC.US: NV, AR, MN, IA, IL, NC, LA, KS, MS, CA, AL, MD, CO, IN, TN, AZ, WI, VAOfficial notice →- 2024-06-19
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Canon Medical System, USA, INC. recalls MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-1520), Vantage Titan MRT-1504 (MEXL-1504), Vantage…
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…
FDA · DeviceCanon Medical System, USA, INC.US: PA, SC, IA, AL, MI, AR, SD, TX, ID, KY, NY, MN, MD, OH, WI, NV, CT, AZ,…Official notice → - 2024-03-13
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Canon Medical System, USA, INC. recalls MRI system: Vantage Elan, Model: MRT-2020
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…
FDA · DeviceCanon Medical System, USA, INC.Worldwide - US Nationwide distribution including in the states of MD, IL, WV,…Official notice → - 2023-08-16
- US
Canon Medical System, USA, INC. recalls INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE CONSOLE
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…
FDA · DeviceCanon Medical System, USA, INC.US Nationwide Distribution: NY, CO, IL, CA, MD, MN, WAOfficial notice → - 2022-11-16
- US
Canon Medical System, USA, INC. recalls Canon Aplio ultrasound system, Model: Aplio i900 TUS-AI900, Aplio i800 TUS-AI800, Aplio i700 TUS-AI700, Aplio a550 CUS-AA550,…
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…
FDA · DeviceCanon Medical System, USA, INC.US: MT, MO, NC, SC, MN, WA, KY, TN, AR, IL, IA, MI, WV, KS, CA, HA, CO, LA,…Official notice → - 2022-09-07
- US
Canon Medical System, USA, INC. recalls INFX-8000V. For radiographic and fluoroscopic studies and intervention.
The fluoroscopic dose rate might exceed the conforming value during biplane fluoroscopy.
Other drugs & medical recalls in the United States
- 2024-02-28
- US
W&H DENTALWERK BUERMOOS GMBH recalls W&H Surgical handpiece S-12. For Surgical treatment of dental hard tissue Model Number: 30061000
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Olympus Corporation of the Americas recalls ESG PK CUTTING FORCEPS, 5MM, 33CM
The jaw may fracture prior to the procedure during the inspection instructed per the IFU, or during the procedure.
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