—#145542

Product

MAGNETOM Aera/Skyra Systems, whole body magnetic resonance imaging systems, Model numbers 10432914, 10432915. Docking station top cover (part no# 10591430) of the removable patient table.

FDA product code: LNH — System, Nuclear Magnetic Resonance Imaging
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K101347
Affected lot / code info: Model # 10432914 and 10432915 Serial Numbers: 42472, 42489, 42477, 46169, 46178, 46175, 42478, 42485

Why it was recalled

The docking station top cover of the removable patient table may contain a magnetic metal plate. When docking/undocking the table, the magnetic top cover may become attracted to the magnet.

Root cause (FDA determination)

Vendor change control

Action the firm took

Siemens mailed to customers on April 13, 2016, a Customer Safety Advisory Notice, MR013/16/S, to inform them of the actions to take to prevent a possible hazard to persons and equipment. Customers were informed that they will be contacted by one of Siemens' service organization who will schedule an appointment to perform a correction, which is to exchange the top cover.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: US nationwide distribution to OH, FL, TN, MN, OH, NY, VA, and MN.

Timeline

Recall initiated: 2016-04-13
Posted by FDA: 2016-05-03
Terminated: 2017-04-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #145542. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.