—#34622

Product

Magnetom Sonata MRI System, Model 7104719

FDA product code: LNH — System, Nuclear Magnetic Resonance Imaging
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K993731
Affected lot / code info: Serial numbers 21151 and 21223

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355-1406

Distribution

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.

Timeline

Recall initiated: 2004-07-28
Posted by FDA: 2004-08-24
Terminated: 2005-01-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #34622. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.