CLASS II Device recall · Reported 19 Apr 2017 · FDA Enforcement Report

Combi Dockable Neurosurgery table recalled

Siemens Medical Solutions USA is recalling Combi Dockable Neurosurgery table for the Siemens Magnetom Aera 5T) and Skyra (3T) MRI, distributed in District of Columbia, Maryland. The recall was initiated on 17 Oct 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number: 10684336, 10684337 Serial Number: 12811002 12811003 12811017

Quantity recalled3 systems distributed in the U.S.

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1770-2017
FDA event ID: 76889
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 17 Oct 2016
FDA classified: 10 Apr 2017
Reported: 19 Apr 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

17 Oct 2016	Recall initiated by company
10 Apr 2017	Classified by FDA	+175 days
19 Apr 2017	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

US Distribution to: DC and MD.

District of Columbia Maryland

Questions about this recall

Is Combi Dockable Neurosurgery table for the Siemens Magnetom Aera 5T) and Skyra (3T) MRI recalled?

Yes. Siemens Medical Solutions USA recalled Combi Dockable Neurosurgery table for the Siemens Magnetom Aera 5T) and Skyra (3T) MRI on 17 Oct 2016. The recall is Class II and its status is Terminated. Recall number Z-1770-2017.

Why was it recalled?

Due to a potential manufacturing error, a rare possibility exists for a sudden drop in table height of the Combi Dockable Table Neurosurgery.

Which lots are affected?

Model Number: 10684336, 10684337 Serial Number: 12811002 12811003 12811017

Where was it sold?

US Distribution to: DC and MD.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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