SOMATOM Force recallZ-0107-2016 · Siemens Medical Solutions USA, Inc · initiated Aug 18, 2015
Class II Terminated All recalls posted in October 2015
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
Software and firmware bugs
FDA root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-0107-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Aug 18, 2015
- Posted by the FDA
- Oct 6, 2015
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 21
- Product code
- JAK
- FDA submissions
- K133589
- Distribution
- Nationwide Distribution
Product description
SOMATOM Force; computed tomography x-ray system. Intended to generate and process cross-sectional images of patients.
Code information (models, lots, serial numbers)
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.
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.
How recalls are matched to devices · Editorial policy · Report an error on this page