SOMATOM Force recallZ-0971-2015 · Siemens Medical Solutions USA, Inc · initiated Dec 3, 2014
Class II Terminated All recalls posted in January 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
Artifacts are found in acquired imaging on the SOMATOM Force.
FDA root cause category: Software Manufacturing/Software Deployment
What the company is doing
A customer advisory notice, dated December 3, 2014, was sent to end users that identified the product, problem, and action to be taken. Customers were informed that new software would be installed via remote access.
Recall details
- Recall number
- Z-0971-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Dec 3, 2014
- Posted by the FDA
- Jan 14, 2015
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 7
- Product code
- JAK
- FDA submissions
- K133589
- Distribution
- PA, MA, MN, SC, MD, and TX.
Product description
SOMATOM Force; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
Code information (models, lots, serial numbers)
Model number: 10742326, serial numbers 75437, 75454, 75464, 75450, 75467, 75475, 75439.
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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