Z-1598-2016Class II

MAGNETOM Aera/Skyra Systems, whole body magnetic resonance imaging systems, Model numbers 10432914, 10432915...

Name: Z-1598-2016 MAGNETOM Aera/Skyra Systems, whole body magnetic resonance imaging systems, Model numbers 10432914, 10432915...
Creator: Siemens Medical Solutions USA, Inc
Published: 2016-04-13
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2016-04-13 / Terminated / root cause: supplier

FDA source

Siemens Medical Solutions USA, Inc began a recall of MAGNETOM Aera/Skyra Systems, whole body magnetic resonance imaging systems, Model numbers 10432914, 10432915. Docking station top cover (part no# 10591430) of... on 2016-04-13. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-1598-2016
Classification: Class II
Status: Terminated
Initiated: 2016-04-13
Posted: 2016-05-03
Terminated: 2017-04-17
Recalling firm: Siemens Medical Solutions USA, Inc.
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.
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: 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 tag: supplier
FDA root cause: Vendor change control
Action: 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.
Quantity in commerce: 8 systems
Distribution: US nationwide distribution to OH, FL, TN, MN, OH, NY, VA, and MN.
Product codes and lots: Model # 10432914 and 10432915 Serial Numbers: 42472, 42489, 42477, 46169, 46178, 46175, 42478, 42485

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1598-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1598-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-11	2016-05-03

Product code LNH

K101347Class IIMagnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. / cleared 2010-10-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)