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FDA (Device enforcement)Recalled 2023-11-27class ii

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

Hazard

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

Details from the source

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: 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 Quantity: 467 units Lot/code info: UDI: 0859942006096 and 0859942006102 Serial Numbers: 940000 through 940535

UPC codes

0859942006096, 0859942006102

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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