FDAFDA · Food and drugs·Recall number Z-2464-2012
Siemens Magnetom Skyra, Verio, Spectra and Biograph MMR Nuclear Magnetic Resonance Imaging System and Tomographic Imager
Published October 3, 2012 · Recall initiated: September 12, 2012
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
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).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Distributor
- Nationwide Distribution - USA including Washington, DC and AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI and Puerto Rico.
- Lot
- Model numbers: 10276755 (Verio), 10684333 (Verio Dot), 10684334 (Verio Dot upgrade), 10432915 (Skyra), 10655588 (Spectra), and 10433372 (Biograph mMR)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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