Home / Recalls / Mirion Technologies (Capintec), Inc. / Z-1892-2024

Z-1892-2024 Class II Ongoing

Recalled by Mirion Technologies (Capintec), Inc. — Florham Park, NJ

FDA device recall Z-1892-2024 was initiated by Mirion Technologies (Capintec), Inc. on April 22, 2024 and is designated Class II. Reason for recall: Complaints of unexpected detachment of the collimator have been reported. The recall status is ongoing. Affected quantity: 1,275 units.

Recall Details

Product Type: Devices
Report Date: June 5, 2024
Initiation Date: April 22, 2024
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1,275 units

Product Description

Captus 4000e Thyroid Uptake System. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.

Reason for Recall

Complaints of unexpected detachment of the collimator have been reported.

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.

Code Information

Lot Code: Model No: 5430-30151; UDI 859942006096, S/N range 940001 through 941398.