Captus 4000e Thyroid Uptake System with Well. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.
Reported: June 5, 2024 Initiated: April 22, 2024 #Z-1893-2024
Product Description
Captus 4000e Thyroid Uptake System with Well. 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.
Details
- Recalling Firm
- Mirion Technologies (Capintec), Inc.
- Units Affected
- 1,275 units
- 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, SWEDEN, SWITZERLAND, TAIWAN, TAIWAN , THAILAND, TURKEY, UNITED KINGDOM, VIETNAM.
- Location
- Florham Park, NJ
Frequently Asked Questions
What product was recalled? ▼
Captus 4000e Thyroid Uptake System with Well. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.. Recalled by Mirion Technologies (Capintec), Inc.. Units affected: 1,275 units.
Why was this product recalled? ▼
Complaints of unexpected detachment of the collimator have been reported.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 5, 2024. Severity: Moderate. Recall number: Z-1893-2024.
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