Captus 4000e Thyroid Uptake System with Well and 2 inch shielding. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot Code: Model No: 5430-30154; UDI 0859942006423; S/N range 940001 through 941398.
  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:
Mirion Technologies (Capintec), Inc.
Reason for Recall:
Complaints of unexpected detachment of the collimator have been reported.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Captus 4000e Thyroid Uptake System with Well and 2 inch shielding. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.

Product Codes/Lot Numbers:

Lot Code: Model No: 5430-30154; UDI 0859942006423; S/N range 940001 through 941398.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1894-2024

Related Recalls

Spring arm failure with Captus 4000e Thyroid Uptake Systems, can cause the collimator to fall downward to its lowest point of travel, causing potential injury with a patient or operator

Nov 27, 2023 Other Medical Devices Nationwide View Details →