Home / Recalls / Mirion Technologies (Capintec), Inc. / Z-1069-2024

Z-1069-2024 Class II Ongoing

Recalled by Mirion Technologies (Capintec), Inc. — Florham Park, NJ

Recall Details

Product Type: Devices
Report Date: February 21, 2024
Initiation Date: November 27, 2023
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 467 units

Product Description

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

Reason for Recall

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

Distribution Pattern

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

Code Information

UDI: 0859942006096 and 0859942006102 Serial Numbers: 940000 through 940535