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Terminated

Siemens MAGNETOM Essenza, Nuclear Magnetic Resonance Imaging System Product Usage: Nuclear magnetic resonance imaging

FDA Recall Z-1675-2012 · Posted 2012-05-25

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLNH
Date Initiated2012-03-30
Date Terminated2014-04-03
Product Quantity97

Reason for Recall

There is an error in the compatibility data sheet which is part of the System Owner Manual

Firm Action

Siemens issued a Customer Safety Advisory Notice letter to affected customers on March 30, 2012. The letter identified the affected product, problem, potential risk and what steps can the user take to avoid the potntial risk of this issue. Siemens is releasing corrected pages of the Operator Manual in order to deliver clear guidance and recommendation for the users. Customers are instructed to ensure that the safety advisory and updated pages are replaced in the System Owner Manual.

Root Cause

Error in labeling

Distribution Pattern

US Nationwide Distribution - including the states of AL, AZ, AR, CA, CO, CT, FL, GA, IL, IN, IA, KS, KY, LA, MS, MO, NE, NJ, NY, NC, OH, OR, PA, TN, TX, WA, WI, WY and Puerto Rico.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K071925MAGNETOM ESSENZASiemens Medical Solutions USA, Inc. · 2007-08-14

Official Source

View FDA Recall →

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

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