FDAClass IIMay 11, 2016

MAGNETOM Aera/Skyra Systems recall

MAGNETOM Aera/Skyra Systems, whole body magnetic resonance imaging systems, Model numbers 10432914, 10432915. Docking station top cover (part no#…

Why was MAGNETOM Aera/Skyra Systems 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model # 10432914 and 10432915 Serial Numbers: 42472, 42489, 42477, 46169, 46178, 46175, 42478, 42485

Product
MAGNETOM Aera/Skyra Systems, whole body magnetic resonance imaging systems, Model numbers 10432914, 10432915. Docking station top cover (part no#…
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
8 systems
Distribution
US nationwide distribution to OH, FL, TN, MN, OH, NY, VA, and MN.
Recall date
May 11, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
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