MAGNETOM Avanto, Espree, Trio A Tim System. Nuclear magnetic resonance imaging.
FDA device recall Z-2021-2011 · posted 2011-04-18 · 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. The potential exists for a cable connection to become overheated, leading to the emission of smoke and possible material damage.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 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,
- Date initiated
- 2011-03-03
- Date posted
- 2011-04-18
- Date terminated
- 2014-12-09
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MAGNETOM TRIO A TIM SYSTEM (K050200) | Siemens Medical Solutions USA, Inc. | 2005-02-28 |
| MAGNETOM ESPREE SYSTEM (K041112) | Siemens Medical Solutions USA, Inc. | 2004-07-21 |
| MAGNETOM AVANTO MR SYSTEM (K032428) | Siemens Medical Solutions USA, Inc. | 2003-10-16 |
| MAGNETOM TRIO SYSTEM (K013586) | Siemens Medical Systems, Inc. | 2001-12-28 |