Reported Jun 29, 2016 · Terminated
Biograph mCT-X 4R, MATERIAL NUMBER 10248670 The Siemens Biograph TruePoint systems are combined X-Ray Computed…
Siemens Medical Solutions USA Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Medical Solutions USA Inc. · 810 Innovation Dr · Knoxville, TN · 37932-2562
Is this the product you have?
- Biograph mCT-X 4R, MATERIAL NUMBER 10248670 The Siemens Biograph TruePoint 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.
- Lot codes and dates
- Serial Numbers
83 of 83 codes
1002100310011004100510061008100910101007101111013110141101511016110171101811020110121101911021110221102311026110251102411027110441102911028110301103111032110331103411037110361103811040110421103911035110451104611041110471104811049110501105111052110541105511056110431105811059110571106111060
- Serial Numbers
- Amount recalled
- 83 units
This recall covers 33 products
The agency filed one notice per product. You are reading one of them; the other 32 are below.
20 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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