Device 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.
Z-1894-2024
Product summary
- Event
- Event 94570
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,275 units
- Official record key
device-enforcement:Z-1894-2024
Official wording
Reason: Complaints of unexpected detachment of the collimator have been reported.
Code information: Lot Code: Model No: 5430-30154; UDI 0859942006423; S/N range 940001 through 941398.
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.
Derived failure modes
-
Unknown
Complaints of unexpected detachment of the collimator have been reported.