Z-1770-2017Class II

Combi Dockable Neurosurgery table for the Siemens MAGNETOM Aera (1.5T) and Skyra (3T) MRI Systems

Name: Z-1770-2017 Combi Dockable Neurosurgery table for the Siemens MAGNETOM Aera (1.5T) and Skyra (3T) MRI Systems
Creator: Siemens Medical Solutions USA, Inc
Published: 2016-10-17
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2016-10-17 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Combi Dockable Neurosurgery table for the Siemens MAGNETOM Aera (1.5T) and Skyra (3T) MRI Systems on 2016-10-17. FDA classified it as Class II and gives the reason as "Due to a potential manufacturing error, a rare possibility exists for a sudden drop in table height of the Combi Dockable Table Neurosurgery". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1770-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-17
Posted: 2017-04-10
Terminated: 2017-10-24
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Combi Dockable Neurosurgery table for the Siemens MAGNETOM Aera (1.5T) and Skyra (3T) MRI Systems
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: Due to a potential manufacturing error, a rare possibility exists for a sudden drop in table height of the Combi Dockable Table Neurosurgery.
Root cause tag: software
FDA root cause: Software design (manufacturing process)
Action: Siemens mailed an Customer Safety Advisory Notice on October 17, 2016, to all affected customers to inform them of the corrective action they plan to take to correct the issue. The notice also informed users of the possible risks to patients and how the corrective action will be implemented. For further questions, please call (610) 448-6461.
Quantity in commerce: 3 systems distributed in the U.S.
Distribution: US Distribution to: DC and MD.
Product codes and lots: Model Number: 10684336, 10684337 Serial Number: 12811002 12811003 12811017

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1770-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1770-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-10

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)