Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Affected serial numbers: 3DA1982001, 3DA2072002, 3DA2072003
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Canon Medical System, USA, INC.
Reason for Recall:
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A

Product Codes/Lot Numbers:

Affected serial numbers: 3DA1982001, 3DA2072002, 3DA2072003

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0142-2022

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