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Recall Observatory FDA recall evidence

Device product

Captus 4000e Thyroid Uptake System with Well. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.

Z-1893-2024

April 22, 2024

Class II

Product summary

Firm
Mirion Technologies (Capintec), Inc.
Event
Event 94570
Status
Ongoing
Classification
Class II
Quantity
1,275 units
Official record key
device-enforcement:Z-1893-2024

Official wording

Reason: Complaints of unexpected detachment of the collimator have been reported.

Code information: Lot Code: Model No: 5430-30152; UDI 0859942006102; 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

    reason.no_named_rule · v1.0.0

    Complaints of unexpected detachment of the collimator have been reported.