Z-1892-2024 Class II Ongoing
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.