Magnetom Harmony MRI System Model number 7106714

Company: Siemens Medical Solutions Usa, Inc
Recall Initiated: July 28, 2004
Posted: August 24, 2004
Terminated: January 25, 2005
Recall Number: Z-1396-04
Quantity: 1 unit
Firm Location: Malvern, PA

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

Distribution

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.

CA CO CT DE FL GA IA IL IN KS MA MI MN MO NC NY OH OR PA TX UT VA

Lot / Code Info

Serial number 10502

Root Cause

Other

Action Taken

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.