Reported Oct 3, 2012 · Terminated
Siemens Magnetom Skyra, Verio, Spectra and Biograph MMR Nuclear Magnetic Resonance Imaging System and Tomographic Imager
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 · 51 Valley Stream Pkwy · Malvern, PA · 19355
Is this the product you have?
- Siemens Magnetom Skyra, Verio, Spectra and Biograph MMR Nuclear Magnetic Resonance Imaging System and Tomographic Imager
- Lot codes and dates
- Model numbers
10276755 (Verio)10684333 (Verio Dot)10684334 (Verio Dot upgrade)10432915 (Skyra)10655588 (Spectra)and 10433372 (Biograph mMR)
- Model numbers
- Amount recalled
- 370
Where it was sold
Why it was recalled
When positioning the Flex Large 4 Coil (part No. 8625761) off-center in left-right direction as it is used for example for hip and shoulder imaging and, in addition at an off-center position with respect to the head-foot direction, the coil can heat up in the area of the electronic housing (white plastic lids).
This product could cause temporary or reversible health problems — stop using it.
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