Mirion Technologies (Capintec), Inc. recalls Captus 4000e Thyroid Uptake Systems- Intended to be used by trained Nuclear Medicine Technologists or Nuclear Medicine…

Recall date

November 27, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1069-2024

FDA classification

Class II

Brand / firm

Mirion Technologies (Capintec), Inc.

Sold / distributed

Nationwide Foreign: AUSTRIA BANGLADESH BRASIL Brazil CANADA CHILE Costa Rica Ecuador France Hanoi Vietnam Hong Kong INDIA ISRAEL ITALY Malaysia PAKISTAN Philippines POLAND Saudi Arabia SOUTH KOREA Spain SWEDEN TAIWAN THAILAND TURKEY UNITED ARAB EMIATES UNITED KINGDOM VIETNAM

Why it was recalled

Spring arm failure with Captus 4000e Thyroid Uptake Systems, can cause the collimator to fall downward to its lowest point of travel, causing potential injury with a patient or operator

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Captus 4000e Thyroid Uptake Systems- Intended to be used by trained Nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures. Models: 5430-30151, 5430-30152, and 5430-30154