Recall Z-2021-2011 ยท LNH System, Nuclear Magnetic Resonance Imaging
Siemens Medical Solutions USA, Inc
MAGNETOM Avanto, Espree, Trio A Tim System. Nuclear magnetic resonance imaging.
| Date | Apr 18, 2011 (initiated Mar 3, 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. The potential exists for a cable connection to become overheated, leading to the emission of smoke and possible material damage. |
| Root cause | Other |
| Action | Siemens Medical Solutions Inc., issued a Customer Safety Advisory Notice dated November 24, 2010, to affected customers via Update Instructions MR029/10S. Affected customers will be notified via hand delivered letter by Siemens Service Engineers at the time of inspection. A future Update instruction will be released for installation of detectors in appropriate locations on systems to switch off the power electronics in the event of a malfunction in the power supply of the gradient coils. Further questions regarding this recall please call (610) 448-3237. |
| Quantity | 1419 |
| Distribution | Product was distributed domestically to hospitals and imaging centers in the District of Columbia, Puerto Rico, AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013586 | MAGNETOM TRIO SYSTEM Siemens Medical Systems, Inc., Dec 28, 2001 |
| K032428 | MAGNETOM AVANTO MR SYSTEM Siemens Medical Solutions USA, Inc., Oct 16, 2003 |
| K041112 | MAGNETOM ESPREE SYSTEM Siemens Medical Solutions USA, Inc., Jul 21, 2004 |
| K050200 | MAGNETOM TRIO A TIM SYSTEM Siemens Medical Solutions USA, Inc., Feb 28, 2005 |