Recall Z-0940-2012 ยท LNH System, Nuclear Magnetic Resonance Imaging
Siemens Medical Solutions USA, Inc
Siemens MAGNETOM Aera/Skyra, model numbers 10432914 and 10432915. Nuclear magnetic resonance imaging system.
| Date | Feb 2, 2012 (initiated Jan 26, 2012) |
| Status | Terminated |
| Reason | During product monitoring firm has discovered 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 existed for a cable connection to become overheated, leading to the emission of smoke and possible material damage. Firm preventively checked the gradient cabl |
| Root cause | Nonconforming Material/Component |
| Action | Siemens Medical Solutions sent a "CUSTOMER SAFETY ADVISORY NOTICE" letter dated November 24, 2010 to all affected customers. The letter described the product, problem, and actions to be taken. Contact the firm at 610-219-4834 for questions regarding this recall. |
| Quantity | 128 |
| Distribution | Nationwide Distribution-including the states of AK, AZ, CA, CT, DE, FL, GA, IL, IN, KS, MD, MA, MI, MN, MO, MT, NE, NH, NJ, NM, NY, NC, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV, and WI. |
| 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 |