Recall Z-2786-2011 ยท LNH System, Nuclear Magnetic Resonance Imaging
Siemens Medical Solutions USA, Inc
Siemens MAGNETOM Systems Symphony, Sonata and Symphony a TIM System Nuclear magnetic resonance imaging system
| Date | Jul 11, 2011 (initiated Mar 31, 2011) |
| Status | Terminated |
| Reason | Firm has discovered during product monitoring that on a few systems the gradient cable connections did not meet their specifications after installation. |
| Root cause | Nonconforming Material/Component |
| Action | Siemens initated their recall of the device on March 31, 2001, by sending a Customer Safety Advisory Notice/Letter to affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were notified that detectors will be installed in appropriate locations on the system, which will switch off the system's power electronics in the event of a malfunction in the power supply of the gradient coils, preventing damage to the system and its environment. |
| Quantity | 440 |
| Distribution | Nationwide Distribution including AL, 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, VT, VA, WA, WV, and WI and Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993731 | SONATA GRADIENTS/MAGNETOM SYMPHONY SYSTEM Siemens Medical Solutions USA, Inc., Dec 23, 1999 |