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Open, Classified

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

FDA Recall Z-1893-2024 · Posted 2024-05-24

Recalling FirmMirion Technologies (Capintec), Inc.
Recall StatusOpen, Classified
Product CodeIZD
Date Initiated2024-04-22
Product Quantity1,275 units

Reason for Recall

Complaints of unexpected detachment of the collimator have been reported.

Firm Action

Consignees were sent an URGENT SAFETY NOTICE via email, dated 4/1/24. Consignees are asked to review the provided notice, share the notice with ass affected personnel, instruct personnel to comply with the provided instructions for safe operation and how to perform a retention plate inspection, and to contact Capintec Technical Support if the inspection shows that the collimator is not properly attached. Capintec Technical Support can be reached by phone at 1-800-631-3826 or at 1-201-825-9500, or by email at [email protected]. Consignees are also asked to confirm receipt of the notification utilizing the provided QR Code or form.

Root Cause

Device Design

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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