Mirion Technologies (Capintec), Inc. recalls Captus 4000e Thyroid Uptake System with Well and 2 inch shielding. Intended to be used to perform Thyroid Uptakes, Staff

Recalled June 5, 2024 · FDA recall Z-1894-2024 · Mirion Technologies (Capintec)

Hazard

Complaints of unexpected detachment of the collimator have been reported. · FDA Class II

Units

1,275 units

Sold at

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.

Description

Complaints of unexpected detachment of the collimator have been reported.

Product

Captus 4000e Thyroid Uptake System with Well and 2 inch shielding. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.

Manufacturer(s)

Mirion Technologies (Capintec), Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →