Z-2021-2011
MAGNETOM Avanto, Espree, Trio A Tim System. Nuclear magnetic resonance imaging
Siemens Medical Solutions USA, Inc. / initiated 2011-03-03 / Terminated
Siemens Medical Solutions USA, Inc began a recall of MAGNETOM Avanto, Espree, Trio A Tim System. Nuclear magnetic resonance imaging on . The reason FDA records is "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...". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-2021-2011
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Product
- MAGNETOM Avanto, Espree, Trio A Tim System. Nuclear magnetic resonance imaging.
- Product code
- LNH System, Nuclear Magnetic Resonance Imaging
- 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.
- FDA 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 in commerce
- 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, WI, and WY(every State except VT).
- Product codes and lots
- Model numbers 10018165, 10018221, 10018222, 7387074, 7391167. 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