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

FDA device recall Z-1892-2024 · posted 2024-05-24 · Open, Classified

Recall details

Recalling firm

Mirion Technologies (Capintec), Inc.

Reason for recall

Complaints of unexpected detachment of the collimator have been reported.

Action taken

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 capintecsupport@mirion.com. Consignees are also asked to confirm receipt of the notification utilizing the provided QR Code or form.

Root cause

Device Design

Status

Open, Classified

Product code

IZD

Quantity 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,

Date initiated

2024-04-22

Date posted

2024-05-24

Location

Florham Park, NJ