Smart CR Digital Computed Radiography System; Model Number: CR-IR346RU

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    All serial numbers.
  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 Medical Systems U.S.A., Inc.
Reason for Recall:
Reports of failure of the device's power supply.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Smart CR Digital Computed Radiography System; Model Number: CR-IR346RU

Product Codes/Lot Numbers:

All serial numbers.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1599-2016

Related Recalls

Software versions 6.0.4 to 6.2.1 using Advanced Reporting -possibility that a previously assigned internal patient database ID can be reused for a new patient. It was discovered that this value does not increase when a patient merge activity is executed in a specific sequence

Apr 30, 2021 Other Medical Devices Nationwide View Details →