FDA Medical Device Recalls (openFDA)
Mirion Technologies (Capintec), Inc.: Captus 4000e Thyroid Uptake System, Models: 1. 5430-30151, 2. 5430-30152, 3. 5430-30154;
- Recall number
- Z-3193-2026
- Recalling firm
- Mirion Technologies (Capintec), Inc.
- Product
- Captus 4000e Thyroid Uptake System, Models: 1. 5430-30151, 2. 5430-30152, 3. 5430-30154;
- Status
- Open, Classified
- Initiated
- 2026-07-20
- Posted
- 2026-09-16
- Terminated
- not on file
- 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 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
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IZD
- Firm FEI
- 2518443
- Firm city
- Florham Park
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28