FDA Device

Siemens Magnetom Harmony Mobile MRI System. Model Number: 4759309, Siemens Medical Solutions USA, Malvern PA, 19355

Hazard

Magnet Quench, unintended- magnet of a mobile MRI system quenched into the exam room.

What You Should Do

Remedy

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.

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Products

Siemens Magnetom Harmony Mobile MRI System. Model Number: 4759309, Siemens Medical Solutions USA, Malvern PA, 19355
Brand
Siemens Medical Solutions USA, Inc
UPC
Serial Numbers: 10018, 10022, 10029, 10032 10036, 10160, 10167, 10255, 10289, 10316, 10386, and 10429.

Units Affected

12 units

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