SOMATOM Definition Flash recallZ-0374-2017 · Siemens Medical Solutions USA, Inc · initiated Oct 19, 2016
Class II Terminated All recalls posted in November 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
Hardware issue that may expose the user to a potential risk for serious injury due to exposure to rotating or electrical parts.
FDA root cause category: Nonconforming Material/Component
What the company is doing
Siemens mailed a Customer Safety Advisory Notice to affected customers on October 19, 2016, to inform them about the hardware issue. The notice provided guidance on risk prevention and actions they are taking to develop a solution to correct the issue. For further questions, please call (610) 448-6471.
Recall details
- Recall number
- Z-0374-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Oct 19, 2016
- Posted by the FDA
- Nov 8, 2016
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 57 systems distributed in USA
- Product code
- JAK
- FDA submissions
- K143416
- Distribution
- Nationwide Distribution
Product description
SOMATOM Definition Flash system, x-ray, tomography, computed
Code information (models, lots, serial numbers)
Model Numbers: 8098027 10430603
Other devices under the same FDA submission
1 device cleared under K143416 — 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 Definition Flash 10430603Siemens Healthcare GmbH · System, x-ray, tomography, computed1 death27 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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