FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: SOMATOM Force, System x-ray, tomography, computed
- Recall number
- Z-0692-2017
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- SOMATOM Force, System x-ray, tomography, computed
- Status
- Terminated
- Initiated
- 2016-10-20
- Posted
- 2016-12-02
- Terminated
- 2017-05-30
- Reason
- Siemens is providing software update version VA50A_SP3 to address the software bugs that were identified through normal field monitoring and the Global Complaint Handling Process. Correction for the problems are as follows: 1. Correction to volumetric misrepresentations of high contrast objects when using ADMIRE. 2. Correction to highly sporadic scan aborts due to temporarily tube currents at 0mA. 3. Correction to missing Microsoft Hotfixes (MS16-001, MS15-135, MS15-088, MS15-048). 4. Correction to highly sporadic image artifacts caused by error signals from high voltage chain at extremely high tube currents. 5. Correction to highly sporadic incomplete image reconstruction due to temporary slow hard disk write speed. 6. Correction to highly sporadic scan aborts due to temporarily high disk load of system disk. 7. Correction to highly sporadic image artifacts generated by scatter correction in case of tube arcings.
- Root cause
- Under Investigation by firm
- Action
- Siemens sent a Customer Information Letter dated November 2, 2016, to customers affected by the recall to inform them of a release of a software update that will provide bug-fixes to improve system performance. Customers will be contacted to arrange a date for onsite installation. For further questions, please call (610) 448-6471.
- Quantity
- 48 units distributed in U.S.
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- Model Number 10742326, Serial Numbers: 75708,75709,75607,75617,75550,75526 75512,75567,75536,75711,75514,75600,75563,75510,75454,75540,75571,75500 75527,75475,75535,75481,75482,75710,75460,75476,75588,75493,75458,75528 75467,75602,75487,75464,75478,75604,75513,75532,75555,75524,75515,75559 75610,75501,75570,75616,75576,75605
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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