Intelli-C, Left side suspended Tabletop, REF: 03400010

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    UDI-DI:05713464000121/Serial Numbers: 647009, 651002, 651006, 666009, 682003
  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:
NRT X-RAY A/S
Reason for Recall:
There is a potential that the drive shaft in the detector up/down (IDE) movement of the X-Ray machine may break which causes the detector to move until it is stopped by the movement end-stop.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Intelli-C, Left side suspended Tabletop, REF: 03400010

Product Codes/Lot Numbers:

UDI-DI:05713464000121/Serial Numbers: 647009, 651002, 651006, 666009, 682003

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1669-2023

Related Recalls

X-ray system C-arm may experience uncontrolled motion if 1) AC motor controller firmware has a faulty setting, 2) the Motor/gear assembly is worn, 3) CAT movement is driven at maximum speed and angulated more than 75 deg. from vertical, and 4) the emergency stop or touch guard is activated during the breaking sequence, which could lead to the C-arm hitting the patient or operator.

Apr 17, 2024 Other Medical Devices Nationwide View Details →