SOMATOM Force, Computed Tomography x-ray system recallZ-1558-2016 · Siemens Medical Solutions USA, Inc · initiated Apr 1, 2016
Class II Terminated All recalls posted in April 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
The Neonate Head protocol with the pediatric kernel Hp38 could result in artefacts and possibly lead to a misdiagnosis (i.e. either non-existing blood or liquid is mimicked in the images or actual existing blood or liquid is not depicted as expected). There is also a risk of a potential misdiagnosis in using this protocol for surgery planning. Investigations revealed an incorrect parameterization of the reconstruction algorithm applied for the pediatric head kernel as cause of the problem.
FDA root cause category: Software design
What the company is doing
Siemens distributed a Safety Advisory Notice dated April 1, 2016, to affected customers The letter identified the affected product, problem, how to avoid potential risks, how the issue will be resolved. and actions to be taken. Customers were asked to observe the safety notice and comply with the corresponding measures until further notice.
Recall details
- Recall number
- Z-1558-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Apr 1, 2016
- Posted by the FDA
- Apr 22, 2016
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 37 CTsystems
- Product code
- JAK
- FDA submissions
- K133589
- Distribution
- US Nationwide Distribution : NC, NH, IL, MA, WA, PA, MD, MN, TX, NY, SC, OH, CA, KY, MT, IA
Product description
SOMATOM Force, Computed Tomography x-ray system intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission.
Code information (models, lots, serial numbers)
SOMATOM Force Material # 10742326, serial numbers 75550, 75526, 75512, 75567, 75536, 75514, 75563, 75510, 75454, 75540, 75571, 75437, 75500, 75527, 75475, 75535, 75481, 75439, 75450, 75482, 75460, 75493, 75476, 75458, 75528, 75467, 75487, 75478, 75513, 75532, 75555, 75524, 75515, 75559, 75501, 75570, 75576, 75450, 75482, 75528, 75576
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