Captus 4000e Thyroid Uptake System, Models: 1. 5430-30151… recallZ-3193-2026 · Mirion Technologies (Capintec), Inc. · initiated Jul 20, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Mirion Technologies (Capintec), Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Device Design
What the company is doing
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]
Recall details
- Recall number
- Z-3193-2026
- Status
- Open, Classified
- Initiated by the company
- Jul 20, 2026
- Posted by the FDA
- Sep 16, 2026
- Recalling firm
- Mirion Technologies (Capintec), Inc.
- Quantity
- 783
- Product code
- IZD
- 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.
Product description
Captus 4000e Thyroid Uptake System, Models: 1. 5430-30151, 2. 5430-30152, 3. 5430-30154;
Code information (models, lots, serial numbers)
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.
Devices named in this recall
3 devices in the FDA device registry whose identifier appears in the recall's code information.
- Captus 4000e Thyroid Uptake SystemMirion Technologies (capintec), Inc. · Probe, Uptake, Nuclear3 recalls5 reports
- Captus 4000e Thyroid Uptake System with Well Captus 4000e Thyroid System with WellMirion Technologies (capintec), Inc. · Probe, Uptake, Nuclear3 recalls4 reports
- Captus 4000e Thyroid Uptake System with 2 in well 5430-30154Mirion Technologies (capintec), Inc. · Probe, Uptake, Nuclear2 recalls0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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