Siemens SOMATOM Definition AS CT Systems Recalled for Injury Risk
Siemens Medical Solutions is recalling 57 SOMATOM Definition AS CT systems due to a hardware issue that may expose users to rotating or electrical parts.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a potential risk of serious injury from rotating or electrical parts, which aligns with the rubric criteria for a Severe rating (score 4) involving significant injury risks.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 57 SOMATOM Definition AS computed tomography (CT) systems distributed nationwide in the United States. The recall is due to a hardware issue that may expose users to a potential risk of serious injury from rotating or electrical parts.
The affected systems are identified by model numbers 8098027 and 10430603. This recall was classified as Class II by the U.S. Food and Drug Administration. The source text does not specify the exact nature of the hardware defect or provide specific instructions for consumers or healthcare facilities beyond the general recall notice.
The recalled product
- Product
- SOMATOM Definition AS 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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