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Terminated

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

FDA Recall Z-1042-2008 · Posted 2008-03-25

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLNH
Date Initiated2007-12-01
Date Terminated2012-10-01
Product Quantity12 units

Reason for Recall

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

Firm 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.

Root Cause

Device Design

Distribution Pattern

Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K970852MAGNETOM PROJECT 024 SYSTEM (NUMARIS 3.5 SOFTWARE)Siemens Medical Solutions USA, Inc. · 1997-06-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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