FDAFDA · Food and drugs·Recall number Z-1069-2024
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
Published February 21, 2024 · Recall initiated: November 27, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Mirion Technologies (Capintec), Inc.
- Distributor
- 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
- Lot
- UDI: 0859942006096 and 0859942006102 Serial Numbers: 940000 through 940535
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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