FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Combi Dockable Neurosurgery table for the Siemens MAGNETOM Aera (1.5T) and Skyra (3T) MRI Systems
- Recall number
- Z-1770-2017
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Combi Dockable Neurosurgery table for the Siemens MAGNETOM Aera (1.5T) and Skyra (3T) MRI Systems
- Status
- Terminated
- Initiated
- 2016-10-17
- Posted
- not on file
- Terminated
- 2017-10-24
- Reason
- 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
- 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
- 3 systems distributed in the U.S.
- Distribution
- US Distribution to: DC and MD.
- Lot, serial or model codes
- Model Number: 10684336, 10684337 Serial Number: 12811002 12811003 12811017
- 510(k) numbers
- ["K101347"]
- PMA numbers
- not on file
- Product code
- LNH
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28