SOMATOM Force, System x-ray, tomography, computed recallZ-0692-2017 · Siemens Medical Solutions USA, Inc · initiated Oct 20, 2016
Class II Terminated All recalls posted in December 2016
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Medical Solutions USA, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-0692-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Oct 20, 2016
- Posted by the FDA
- Dec 2, 2016
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 48 units distributed in U.S.
- Product code
- JAK
- FDA submissions
- K133589
- Distribution
- Nationwide Distribution.
Product description
SOMATOM Force, System x-ray, tomography, computed
Code information (models, lots, serial numbers)
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
Other devices under the same FDA submission
1 device cleared under K133589 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Somatom Force 10742326Siemens Healthcare GmbH · System, x-ray, tomography, computed3 deaths28 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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