Mirion Technologies (Capintec), Inc.: Device Recall
Recall #Z-1892-2024 · 04/22/2024
Class II: Risk
Recall Details
- Recall Number
- Z-1892-2024
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Mirion Technologies (Capintec), Inc.
- Status
- Ongoing
- Date Initiated
- 04/22/2024
- Location
- Florham Park, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,275 units
Reason for Recall
Complaints of unexpected detachment of the collimator have been reported.
Product Description
Captus 4000e Thyroid Uptake System. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.
Distribution Pattern
Worldwide - US Nationwide distribution and the countries of ALGERIA, AUSTRALIA, AUSTRIA, BANGLADESH, CANADA, CHILE, CHINA, COSTA RICA, CROATIA, FRANCE, GERMANY, GUAM, HONDURAS, HUNGARY, INDIA, ISRAEL, ISREAL, ITALY, JAPAN, KOREA, LATVIA, MALAYSIA, NETHERLANDS, NEW ZEALAND, PAKISTAN, PHILIPPINES, PHILIPPINES , PHILLIPINES, PUERTO RICO, QATAR, SAUDI ARABIA, SERBIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TAIWAN , THAILAND, TURKEY, UNITED KINGDOM, VIETNAM.
Other Recalls by Mirion Technologies (Capintec), Inc.
- Class II: Risk 04/22/2024
- Class II: Risk 04/22/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.