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Captus 4000e Thyroid Uptake System with Well. Intended to… recallZ-1893-2024 · Mirion Technologies (Capintec), Inc. · initiated Apr 22, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Mirion Technologies (Capintec), Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Complaints of unexpected detachment of the collimator have been reported.

FDA root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-1893-2024
Status
Open, Classified
Initiated by the company
Apr 22, 2024
Posted by the FDA
May 24, 2024
Recalling firm
Mirion Technologies (Capintec), Inc.
Quantity
1,275 units
Product code
IZD
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.

Product description

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

Code information (models, lots, serial numbers)

Lot Code: Model No: 5430-30152; UDI 0859942006102; S/N range 940001 through 941398.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 94570).

Sources and updates

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