MAGNETOM Avanto, Espree, Trio A Tim System. Nuclear magnetic resonance imaging.
FDA Recall Z-2021-2011 · Posted 2011-04-18
Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLNH
Date Initiated2011-03-03
Date Terminated2014-12-09
Product Quantity1419
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.
Firm 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.
Root Cause
Other
Distribution Pattern
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).
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
K050200MAGNETOM TRIO A TIM SYSTEMSiemens Medical Solutions USA, Inc. · 2005-02-28K041112MAGNETOM ESPREE SYSTEMSiemens Medical Solutions USA, Inc. · 2004-07-21K032428MAGNETOM AVANTO MR SYSTEMSiemens Medical Solutions USA, Inc. · 2003-10-16K013586MAGNETOM TRIO SYSTEMSiemens Medical Systems, Inc. · 2001-12-28
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.