Recall Z-3193-2026 ยท IZD Probe, Uptake, Nuclear
Mirion Technologies (Capintec), Inc.
Captus 4000e Thyroid Uptake System, Models: 1. 5430-30151, 2. 5430-30152, 3. 5430-30154;
| Date | Sep 16, 2026 (initiated Jul 20, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Device Design |
| 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 |
| 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, UNI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.