Device recall
Captus 4000e Thyroid Uptake System, Models: 1. 5430-30151, 2. 5430-30152, 3. 5430-30154;
- Recall number
- Z-3193-2026
- Event id
- 99677
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Mirion Technologies (Capintec), Inc.
- Report date
- Sep 23, 2026
- Posted
- Sep 16, 2026
- Initiated
- Jul 20, 2026
- Center classification date
- Sep 16, 2026
- Product code
- IZD
- Device type
- Probe, Uptake, Nuclear
- 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
- Quantity
- 783
- Code info
- 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.
- 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.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Florham Park, NJ, United States