Recall Z-1364-2012 ยท LNH System, Nuclear Magnetic Resonance Imaging
Siemens Medical Solutions USA, Inc
Siemens MAGNETOM Verio Use: Nuclear resonance imaging system
| Date | Apr 2, 2012 (initiated Mar 26, 2012) |
| Status | Terminated |
| Reason | During product monitoring, Siemens has discovered that the gradient cable connections on a few systems did not meet their specifications after installation. The cable connections overheated, leading to the emission of smoke and possible material damage. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, Siemens Medical Solutions USA, Inc., sent a "Customer Safety Advisory Notice" including Update Instruction MR028/10/S dated March 2012 to affected customers via hand delivery by Siemens Service Engineer . The notice described the product, problem and actions to be taken. The customers were instructed to create a COBR image and to make a copy of the attached "Completion Protocol" fill it out and file in their corresponding binder. Siemens Service Engineer performed an all gradient cable connection visual inspection as well as torque check on the connecting screws at the sites and t |
| Quantity | 245 |
| Distribution | Nationwide distribution to Washington, DC and the following States: AL, AK, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KY, LA, MD, MA, MI, MN, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WV, and WI. Government Accounts include: BROOKE ARMY MEDICAL CENT |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072237 | MAGNETOM VERIO Siemens Medical Solutions USA, Inc., Oct 10, 2007 |