Recall Z-2979-2011 ยท LNH System, Nuclear Magnetic Resonance Imaging
Siemens Medical Solutions USA, Inc
MAGNETOM Aera/Skyra System - Nuclear magnetic resonance imaging
| Date | Aug 10, 2011 (initiated Jun 20, 2011) |
| Status | Terminated |
| Reason | Firm discovered during product monitoring that on a few systems the gradient cable connections did not meet their specifications after installation. Locally, the cable connections overheated, making servicing necessary.The potential exists for a cable connection to become overheated, leading to the emission of smoke and possible material damage. |
| Root cause | Nonconforming Material/Component |
| Action | Siemens sent a "CUSTOMER SAFETY ADVISORY NOTICE" letter dated June 20, 2011 to all affected customers. The letter describes the product, problem, and actions that will be taken. The letter informs customers that an inspection of the gradient cable connections and an emergency shutdown mechanism will be installed by a field service representative during a visit to all affected locations. |
| Quantity | 26 |
| Distribution | Nationwide Distribution-USA (nationwide) including the states of AK, FL, GA, IL, MA, MI, MN, MT, NC, NJ, NY, OH, TX, UT, VA, WA, and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101347 | MAGNETOM AERA; MAGNETOM SKYRA Siemens Medical Solutions USA, Inc., Oct 1, 2010 |