• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of October 3, 2012

  • Print
  • Share
  • E-mail
-

Product Detail

Product Description Siemens Magnetom Skyra, Verio, Spectra and Biograph MMR Nuclear Magnetic Resonance Imaging System and Tomographic Imager
Recall Number Z-2464-2012
Classification Class II
Code Info Model numbers: 10276755 (Verio), 10684333 (Verio Dot), 10684334 (Verio Dot upgrade), 10432915 (Skyra), 10655588 (Spectra), and 10433372 (Biograph mMR)
Product Distributed Qty 370
Reason For Recall 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).

Event Detail

Event Id 63197
Product Type Devices
Status Ongoing
Recalling Firm Siemens Medical Solutions USA, Inc
City Malvern
State PA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-09-12
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern 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.
-
-