FDA-Device2026-09-23Class IIPROCESSING DEFECT
Mirion Captus 4000e Thyroid Uptake System recalled for tension bolt failure risk
What this means
The tension bolt in certain Mirion Captus 4000e thyroid imaging systems can fail, allowing the spring arm to unexpectedly drop to its lowest position, about 25 inches from the ground. This affects specific models shipped between April 2019 and February 2024 that have not yet received the redesigned arm. No injuries have been reported.
- Check your device serial number against the range 940548–941398 and the three affected model numbers (5430-30151, 5430-30152, 5430-30154).
- Contact Mirion Technologies for inspection or replacement of the arm assembly.
- Do not operate the device if you suspect the tension bolt is loose or damaged.
The agency's original wording
Hazard
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
783
Manufactured in
7 Vreeland Rd, N/A, Florham Park, NJ, United States
Products
Captus 4000e Thyroid Uptake System, Models: 1. 5430-30151, 2. 5430-30152, 3. 5430-30154;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3193-2026Want us to check the next one for you?
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