Mirion Technologies (Capintec), Inc.: Captus 4000e Thyroid Uptake System with Well. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.

Hazard

Complaints of unexpected detachment of the collimator have been reported.

Details from the source

Reason for recall: Complaints of unexpected detachment of the collimator have been reported. Distribution: 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, Quantity: 1,275 units Lot/code info: Lot Code: Model No: 5430-30152; UDI 0859942006102; S/N range 940001 through 941398.

UPC codes

0859942006102

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.