FDAFDA · Food and drugs·Recall number Z-1999-2016
BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10528956 Product Usage: 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 June 22, 2016 · Recall initiated: April 25, 2016
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
The bracket that is used to lift the cover has bolts that were not welded in potentially causing the cover to fall down during service.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Medical Solutions USA Inc.
- Distributor
- Worldwide Distribution - US Nationwide and the countries of China and Malaysia.
- Lot
- Serial Number 11009
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.