Class 2 Device Recall MAGNETOM Avanto, Espree, Trio A Tim System

• Date Initiated by Firm: March 03, 2011
• Date Posted: April 18, 2011
• Recall Status: Terminated on December 09, 2014
• Recall Number: Z-2021-2011
• Recall Event ID: 58080
• 510(K)Number: K032428 K041112 K050200 K013586
• Product Classification: System Nuclear Magnetic Resonance Imaging - Product Code LNH
• Product: MAGNETOM Avanto, Espree, Trio A Tim System.; ; Nuclear magnetic resonance imaging.
• Code Information: Model numbers 10018165, 10018221, 10018222, 7387074, 7391167. 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• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 51 Valley Stream Pkwy; Malvern PA 19355
• For Additional Information Contact: Meredith A. Adams; 610-448-3237
• Manufacturer 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 Determined 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).
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LNH and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.; 510(K)s with Product Code = LNH and Original Applicant = SIEMENS MEDICAL SYSTEMS, INC.