Z-3193-2026Class II

Captus 4000e Thyroid Uptake System, Models: 1. 5430-30151, 2. 5430-30152, 3. 5430-30154

Name: Z-3193-2026 Captus 4000e Thyroid Uptake System, Models: 1. 5430-30151, 2. 5430-30152, 3. 5430-30154
Creator: Mirion Technologies (Capintec), Inc.
Published: 2026-07-20
License: https://open.fda.gov/license/

Mirion Technologies (Capintec), Inc. / initiated 2026-07-20 / Open, Classified

FDA source

Recall record

Recall number: Z-3193-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-20
Posted: 2026-09-16
Recalling firm: Mirion Technologies (Capintec), Inc.
Product: Captus 4000e Thyroid Uptake System, Models: 1. 5430-30151, 2. 5430-30152, 3. 5430-30154;
Product code: IZD Probe, Uptake, Nuclear
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 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 [email protected]
Quantity in commerce: 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.
Product codes and 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3193-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3193-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-16

Product code IZD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-18. View this recall on fda.gov (opens on fda.gov)