Captus 4000e Thyroid Uptake System, Models: 1. 5430-30151, 2. 5430-30152, 3. 5430-30154;
FDA Recall Z-3193-2026 · Posted 2026-09-16
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Recalling FirmMirion Technologies (Capintec), Inc.
Recall StatusOpen, Classified
Product CodeIZD
Date Initiated2026-07-20
Product Quantity783
Reason for Recall
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.
Firm Action
On July 20, 2026 URGENT SAFETY NOTICE letters were emailed to customers. Actions to be taken:
1. Review this Alert and ensure that all affected personnel, including all operators of Captus 4000e Thyroid Uptake Systems, are aware of the contents.
2. Operate and inspect the device per the instructions provided.
If your inspection shows that the collimator is not properly attached, please contact Capintec Technical Support at the phone number or email listed below. If you have any questions about this Inspection procedure of your Captus 4000 System, please contact Capintec Technical Support. If you notice any unusual change in the performance or functional response of the arm in your system (e.g. arm is making an unusual noise or arm does not move smoothly at any articulation joint), please contact Capintec Technical Support immediately.
Capintec Technical Support:
1-800-631-3826
1-201-825-9500
[email protected]
Root Cause
Device Design
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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