Drugs & medicalClass II

Canon Medical System, USA, INC. recalls Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, Item Numbers: INFX-8000V, INFX-8000C, INFX-8000F,…

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…

Read the official notice →
Date
2022-01-19
Country
United States
Brand
Canon Medical System
Product
Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, Item Numbers: INFX-8000V, INFX-8000C, INFX-8000F, and…
Classification
Class II
Units
US Nationwide distribution in the states of DE, FL, LA, MT, NJ, OH, and WV.
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 Details may be shortened or out of date; the official notice is the authoritative source.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

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. 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

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    FDA · DeviceCanon Medical System, USA, INC.US: CA, LAOfficial notice →
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    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…

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  5. 2022-11-16
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    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…

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  7. 2022-09-07
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    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.

    FDA · DeviceCanon Medical System, USA, INC.US Nationwide DistributionOfficial notice →
  9. 2022-07-06
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    Canon Medical System, USA, INC. recalls System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: INFX-8000C/BF, INFX-8000C/BH, INFX-8000C/SW

    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.

    FDA · DeviceCanon Medical System, USA, INC.U.S.: CA, CO, FL, NY, and WY O.U.S.: NoneOfficial notice →
  11. 2021-10-27
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    Canon Medical System, USA, INC. recalls Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A

    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…

    FDA · DeviceCanon Medical System, USA, INC.US Nationwide distribution in the states of NV, AR MN.Official notice →
All 16 Canon Medical System recalls →

Other drugs & medical recalls in the United States

  1. 2022-01-26
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    Geri-Care Pharmaceuticals Recalls Over-the-Counter Drugs Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning

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    CPSCGeri-Care Pharmaceuticals, of Brooklyn, New YorkAbout 800Official notice →
  3. 2022-01-19
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See all drugs & medical recalls →