MAGNETOM Aera/Skyra System - Nuclear magnetic resonance imaging
FDA device recall Z-2979-2011 · posted 2011-08-10 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 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.
- Date initiated
- 2011-06-20
- Date posted
- 2011-08-10
- Date terminated
- 2014-01-14
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MAGNETOM AERA; MAGNETOM SKYRA (K101347) | Siemens Medical Solutions USA, Inc. | 2010-10-01 |