🔍 RecallPedia

The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE) family of digital x-ray detectors coupled.

Class I - Dangerous
🏥 Medical Devices Recalled: November 23, 2023 FUJIFILM Healthcare Americas Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    All serial numbers shipped from FUJIFILM
  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:
FUJIFILM Healthcare Americas Corporation
Reason for Recall:
When the key switch is turned on, the exposure conditions are set to the default values (85kV, 1.6 mAs, approx. 0.13mGy@ SID 1m) intended for adult chest imaging. In addition, if exposure conditions are set from the console while the key switch is off, the set exposure conditions will not be reflected.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE) family of digital x-ray detectors coupled.

Product Codes/Lot Numbers:

All serial numbers shipped from FUJIFILM

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-3158-2024

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