🔍 RecallPedia

GE Healthcare Brivo XR 285 Mobile general purpose radiographic imaging of the human head and body.

Class I - Dangerous
🏥 Medical Devices Recalled: September 20, 2012 GE Healthcare Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    part numbers:5555000, 5555000-2
  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:
GE Healthcare, LLC
Reason for Recall:
It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product, Brivo XR285amx, Optima XR200amx, Optima XR22Oamx and Optima XR200amx with Digital Upgrade, related to Technique Accuracy as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-2-54.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

GE Healthcare Brivo XR 285 Mobile general purpose radiographic imaging of the human head and body.

Product Codes/Lot Numbers:

part numbers:5555000, 5555000-2

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0200-2013

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