FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: 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.
- Recall number
- Z-1598-2016
- 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.
- Status
- Terminated
- Initiated
- 2016-04-13
- Posted
- 2016-05-03
- Terminated
- 2017-04-17
- Reason
- 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
- 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
- 8 systems
- Distribution
- US nationwide distribution to OH, FL, TN, MN, OH, NY, VA, and MN.
- Lot, serial or model codes
- Model # 10432914 and 10432915 Serial Numbers: 42472, 42489, 42477, 46169, 46178, 46175, 42478, 42485
- 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