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Terminated

Siemens MAGNETOM Aera/Skyra, model numbers 10432914 and 10432915. Nuclear magnetic resonance imaging system.

FDA Recall Z-0940-2012 · Posted 2012-02-02

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLNH
Date Initiated2012-01-26
Date Terminated2014-01-31
Product Quantity128

Reason for Recall

During product monitoring firm has discovered 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 existed for a cable connection to become overheated, leading to the emission of smoke and possible material damage. Firm preventively checked the gradient cabl

Firm Action

Siemens Medical Solutions sent a "CUSTOMER SAFETY ADVISORY NOTICE" letter dated November 24, 2010 to all affected customers. The letter described the product, problem, and actions to be taken. Contact the firm at 610-219-4834 for questions regarding this recall.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide Distribution-including the states of AK, AZ, CA, CT, DE, FL, GA, IL, IN, KS, MD, MA, MI, MN, MO, MT, NE, NH, NJ, NM, NY, NC, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV, and WI.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K101347MAGNETOM AERA; MAGNETOM SKYRASiemens Medical Solutions USA, Inc. · 2010-10-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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