Z-1400-04

Magnetom Sonata MRI System, Model 7388148

Name: Z-1400-04 Magnetom Sonata MRI System, Model 7388148
Creator: Siemens Medical Solutions USA, Inc
Published: 2004-07-28
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2004-07-28 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Magnetom Sonata MRI System, Model 7388148 on 2004-07-28. The reason FDA records is "An input error can be made with Magnetom MRI software. Software allows users to manually change Transmit Reference Voltage in certain windows". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1400-04
Status: Terminated
Initiated: 2004-07-28
Posted: 2004-08-24
Terminated: 2005-01-25
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Magnetom Sonata MRI System, Model 7388148
Product code: LNH System, Nuclear Magnetic Resonance Imaging
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
Root cause tag: software
FDA root cause: Other
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.
Quantity in commerce: 2 units
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.
Product codes and lots: Serial numbers 16502 and 16509

Product code LNH

K993731Class IISonata Gradients/magnetom Symphony SystemSiemens Medical Solutions USA, Inc. / cleared 1999-12-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)