Z-1042-2008

Siemens Magnetom Harmony Mobile MRI System. Model Number: 4759309, Siemens Medical Solutions USA, Malvern PA...

Name: Z-1042-2008 Siemens Magnetom Harmony Mobile MRI System. Model Number: 4759309, Siemens Medical Solutions USA, Malvern PA...
Creator: Siemens Medical Solutions USA, Inc
Published: 2007-12-01
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2007-12-01 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens Magnetom Harmony Mobile MRI System. Model Number: 4759309, Siemens Medical Solutions USA, Malvern PA, 19355 on 2007-12-01. The reason FDA records is "Magnet Quench, unintended- magnet of a mobile MRI system quenched into the exam room". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1042-2008
Status: Terminated
Initiated: 2007-12-01
Posted: 2008-03-25
Terminated: 2012-10-01
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens Magnetom Harmony Mobile MRI System. Model Number: 4759309, Siemens Medical Solutions USA, Malvern PA, 19355
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: Magnet Quench, unintended- magnet of a mobile MRI system quenched into the exam room.
Root cause tag: design
FDA root cause: Device Design
Action: The firm issued an Update Instruction package to consignees 12/07. As an immediate measure, the recalling firm is initiating field checks of mobile MRI systems per Update Instruction MR039/07/S. This update defines a safety inspection for mobile systems, including checks for potential ice formation and proper configuration of venting assemblies.
Quantity in commerce: 12 units
Distribution: Nationwide Distribution
Product codes and lots: Serial Numbers: 10018, 10022, 10029, 10032 10036, 10160, 10167, 10255, 10289, 10316, 10386, and 10429.

Product code LNH

K970852Class IIMagnetom Project 024 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. / cleared 1997-06-05

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)