FDA Medical devices recall ·
Captus 4000e Thyroid Uptake System, Models: 1. 5430-30151, 2… recall
- Recall number
- Z-3193-2026
- Date
- (initiated July 20, 2026)
- Company / brand
- Mirion Technologies (Capintec), Inc.
7 Vreeland Rd, Florham Park, NJ, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 783
- Hazard tags
- Fall
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Captus 4000e Thyroid Uptake System, Models: 1. 5430-30151, 2. 5430-30152, 3. 5430-30154;
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot 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.
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.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-3193-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.