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Terminated

Magnetom Sonata MRI System, Model 7104719

FDA Recall Z-1401-04 · Posted 2004-08-24

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLNH
Date Initiated2004-07-28
Date Terminated2005-01-25
Product Quantity2 units

Reason for Recall

An input error can be made with Magnetom MRI software. Software allows users to manually change Transmit Reference Voltage in certain windows

Firm Action

The recalling firm issued a Customer Safety Advisory letter via certified mail to their customers per Update Instructions MR028/04/S. The letter informs customers of the potential issue and provides instructions to avoid its occurence.

Root Cause

Other

Distribution Pattern

The products were shipped to 39 medical facilities in CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, MA, MI, MN, MO, NC, NY, OH, OR, PA, TX, UT, and VA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K993731SONATA GRADIENTS/MAGNETOM SYMPHONY SYSTEMSiemens Medical Solutions USA, Inc. · 1999-12-23

Official Source

View FDA Recall →

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

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