FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: SOMATOM Force; computed tomography x-ray system. Intended to generate and process cross-sectional images of patients.
- Recall number
- Z-0107-2016
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- SOMATOM Force; computed tomography x-ray system. Intended to generate and process cross-sectional images of patients.
- Status
- Terminated
- Initiated
- 2015-08-18
- Posted
- 2015-10-06
- Terminated
- 2017-05-08
- Reason
- Software and firmware bugs
- Root cause
- Software design
- Action
- Customers will be notified via the system interface and e-mail or U.S. postal mailing via a Customer Advisory Notice. If necessary the advisory letter may be hand delivered. The letter informed customers that the safety related issues identified were resolved by SW-Version VA50A_SP2. The update will be remotely pushed to affected systems. The letter also advised customers to notify anyone in their organization that should be aware of the information. In the event that the device had been sold, the notice should be forwarded to the new owner, and the firm should be informed of the new owner.
- Quantity
- 21
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Model Number of device- 10742326 with serial numbers: 75514 75512 75510 75454 75437 75500 75475 75481 75439 75450 75482 75460 75493 75476 75458 75467 75487 75478 75513 75515, and 75501.
- 510(k) numbers
- ["K133589"]
- 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