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Ongoing FDAEvent 99677 (29 days ago)

Captus 4000e Thyroid Uptake System

Potential for failure of the tension bolt which would allow the spring arm to unexpectedly fall to its lowest position, which is approximately 25 inches (63.5 cm) from the ground.

Moderate risk

Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.

FDA Class II recall · How risk is rated

What to do

What happened

Mirion Technologies (Capintec), Inc., of Florham Park, New Jersey, began a recall on July 20, 2026, of the Captus 4000e Thyroid Uptake System, models 5430-30151, 5430-30152, and 5430-30154, due to potential failure of the tension bolt, which could allow the spring arm to unexpectedly fall to its lowest position, approximately 25 inches (63.5 cm) from the ground.

The FDA added the recall to its Enforcement Report on September 16, 2026, with worldwide distribution including the US nationwide and numerous other countries.

Summary by Recall Canary from the FDA notice.

What to do

We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:

  1. A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
  2. Talk to your health care provider before you stop using it.

Is yours affected?

Affected if its model number and UDI-DI are listed under that product.

  1. Captus 4000e Thyroid Uptake System

    Model
    • 5430-30151
    • 5430-30152
    • 5430-30154
    UDI-DI
    • 00859942006096
    • 00859942006102
    • 00859942006423

Details

Company began the recall
Sold in

Worldwide distribution - US Nationwide and the countries of ALGERIA, AUSTRIA, BANGLADESH, BRASIL, Brazil, CANADA, CHILE, Costa Rica, Ecuador, France, Hanoi Vietnam, Hong Kong, INDIA, ISRAEL, ITALY, Malaysia, Philippines, POLAND, Saudi Arabia, SOUTH KOREA, Spain, SWEDEN, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIATES, UNITED KINGDOM, VIETNAM.

Event ID
99677
Recall No.
Z-3193-2026
Company
Mirion Technologies (Capintec), Inc.Florham Park, New Jersey
Recall type
Voluntary: Firm initiated
Customers told by
E-Mail
  1. Company began the recall

  2. Added to FDA's Enforcement Report · Classified by FDA

  3. Listed on Recall Canary

  4. In FDA's weekly enforcement report

  5. Summary updated

Summary by Recall Canary, written with AI · summary updated Oct 2, 2026 · primary source: U.S. Food and Drug Administration