FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: SOMATOM Scope, Computed tomography x-ray system
- Recall number
- Z-0919-2017
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- SOMATOM Scope, Computed tomography x-ray system
- Status
- Terminated
- Initiated
- 2016-11-22
- Posted
- not on file
- Terminated
- 2017-05-30
- Reason
- Siemens is providing a new installation of the Residual Current Monitor (RCM) in the Line Connection Box (LCB) to resolve a potential defect that could lead to a power cutout during use of the SOMATOM Scope, Scope Power and Perspective systems.
- Root cause
- Nonconforming Material/Component
- Action
- Siemens mailed on December 01, 2016 a Customer Safety Notice to affected customers to inform them of a corrective action that is being performed to prevent a possible hazard to persons and equipment. The notice explained the underlying issue, the effect the issue has on the system, the associated risks and actions they will take to correct the issue. In addition, customers will receive a Customer Safety Notice via Hand Delivery from the Siemens Customer Service Engineer at the scheduled appointment for the corrective installation.
- Quantity
- 13 systems
- Distribution
- Distributed to: IL IL GA SC SD OK NY MI IN MD AR
- Lot, serial or model codes
- Model # 10967666 Serial Number:59376 91766 91767 115456 115454 59380 77560 98840 77557 91758 59377 59378 115451
- 510(k) numbers
- ["K151749"]
- PMA numbers
- not on file
- Product code
- JAK
- 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