Reported Jun 29, 2016 · Terminated
BIOGRAPH 6 TruePoint, Material Number 10097289 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 6 TruePoint, Material Number 10097289 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
102 of 102 codes
1003100410091013101610281031103210331036103710381040104210521059106610701083109544983455114551445519455234553045531455354553745538455404554245543455504555145567455684556945570455714557345575455774557845579455814558345588455934559545599456024560345604456074560945610456114561345614
- Serial Numbers
- Amount recalled
- 102 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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