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Terminated

MAGNETOM Aera/Skyra System - Nuclear magnetic resonance imaging

FDA Recall Z-2979-2011 · Posted 2011-08-10

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLNH
Date Initiated2011-06-20
Date Terminated2014-01-14
Product Quantity26

Reason for Recall

Firm discovered during product monitoring 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 exists for a cable connection to become overheated, leading to the emission of smoke and possible material damage.

Firm Action

Siemens sent a "CUSTOMER SAFETY ADVISORY NOTICE" letter dated June 20, 2011 to all affected customers. The letter describes the product, problem, and actions that will be taken. The letter informs customers that an inspection of the gradient cable connections and an emergency shutdown mechanism will be installed by a field service representative during a visit to all affected locations.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide Distribution-USA (nationwide) including the states of AK, FL, GA, IL, MA, MI, MN, MT, NC, NJ, NY, OH, TX, UT, VA, WA, and WV.

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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