FDAFDA · Food and drugs·Recall number Z-1894-2024
Captus 4000e Thyroid Uptake System with Well and 2 inch shielding. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.
Published June 5, 2024 · Recall initiated: April 22, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Complaints of unexpected detachment of the collimator have been reported.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Mirion Technologies (Capintec), Inc.
- Distributor
- 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.
- Lot
- Lot Code: Model No: 5430-30154; UDI 0859942006423; S/N range 940001 through 941398.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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