FDAFDA · Food and drugs·Recall number Z-0810-2015
Biograph mCT S(64)-4R, System Material Number 10248672. The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Published December 24, 2014 · Recall initiated: November 13, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Possibility for system display freeze during CT interventional procedures.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Medical Solutions USA Inc.
- Distributor
- Distributed in the states of NC and MA and the countries of Australia, Canada, Switzerland, and Germany.
- Lot
- Serial Number: 11021
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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