Recall Z-3193-2026
Mirion Technologies (Capintec), Inc. · initiated July 20, 2026
Product
Captus 4000e Thyroid Uptake System, Models: 1. 5430-30151, 2. 5430-30152, 3. 5430-30154;
Codes / lots: Affected Units: Captus 4000: 1. Model 5430-30151; UDI-DI: 00859942006096; 2. Model 5430-30152; UDI-DI: 00859942006102; 3. Model 5430-30154; UDI-DI: 00859942006423; Devices shipped from April 2019 through February 2024, Serial Numbers 940548 through 941398, that have NOT already replaced the original arm with the redesigned arm.
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.
FDA-determined cause: Device Design
Action taken
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 capintecsupport@mirion.com
Details
- Recall number
- Z-3193-2026
- Initiated
- July 20, 2026
- Posted by FDA
- September 16, 2026
- Product code
- IZD – Probe, Uptake, Nuclear
- Quantity
- 783
- Distribution
- 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.
- Recalling firm
- Mirion Technologies (Capintec), Inc., Florham Park, NJ