Mirion Technologies (Capintec), Inc. recalls Captus 4000e Thyroid Uptake System
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Captus 4000e Thyroid Uptake System, Models: 1. 5430-30151, 2. 5430-30152, 3. 5430-30154;
Lot / code information
- Model
- 5430-30151
- UDI
- 00859942006096; 2
- Model
- 5430-30152
- UDI
- 00859942006102; 3
- Model
- 5430-30154
- UDI
- 00859942006423; Devices shipped from April 2019 through February 2024
- Serial #
- 940548 through 941398, that have NOT already replaced the original arm with the redesigned arm
What the firm 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 capintecsupport@mirion.com
DistributionShow detailsHide
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.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-3193-2026
- FDA device classification · IZDOfficial FDA classification for this device type
- CFR regulation · 21 CFR 892.1320The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Mirion Technologies (Capintec), Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
More Class II recalls
PI CARDIA LTD recalls Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US
Transfemoral catheter, positing arm may detached due to weld issue.
- Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures
- Process control
ICU Medical, Inc. recalls CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes: 21-…
Reservoirs may exhibit medication leakage at the joint between luer connector and tubing. Issue could result in delay or interruption of therapy, under delivery of medication, exposure to infectious or toxic agents, or a…
- I.V. Fluid Transfer Set
- Process control
F & A Foundation recalls Reign Medical Clench Staple System (Compression)
Bone fixation staple requires a new 510(k); the performance characteristics of this device have not been adequately established.
- Bone Fixation Staple
- No Marketing Application
