Siemens SOMATOM Definition Flash CT Systems Recalled for Injury Risk
Siemens is recalling 57 SOMATOM Definition Flash CT systems in the US due to a hardware issue that may expose users to rotating or electrical parts.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states a 'potential risk for serious injury' due to exposure to rotating or electrical parts, which aligns with the rubric criterion for 'significant injury' reports or risk-of-harm products where injury has not yet been reported but the potential is severe.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 57 SOMATOM Definition Flash computed tomography (CT) systems distributed nationwide in the United States. The recall involves model numbers 8098027 and 10430603.
The recall is being conducted because of a hardware issue that may expose the user to a potential risk for serious injury due to exposure to rotating or electrical parts. The source text does not specify the exact nature of the hardware defect or the specific conditions under which the exposure occurs.
Hospitals and medical facilities that have purchased these systems should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address the issue. The source text does not provide specific contact details or remediation steps.
The recalled product
- Product
- SOMATOM Definition Flash system, x-ray, tomography, computed
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 57
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model Numbers: 8098027 10430603
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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