Recalls / —

—#67974

Product

Siemens Magnetom Harmony sygno. Model Number: 7104693, Siemens Medical Solutions USA, Malvern PA, 19355

FDA product code

LNH — System, Nuclear Magnetic Resonance Imaging

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K970852

Affected lot / code info

Serial Numbers: 11006, 11044, 11065, 11090, 11102, 11112, 11115, 11127, 11157, and 11162.

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

51 Valley Stream Pkwy, Malvern, Pennsylvania 19355-1406

Distribution

Distribution pattern

Nationwide Distribution

Timeline

Recall initiated

2007-12-01

Posted by FDA

2008-03-25

Terminated

2012-10-01

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #67974. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.