Siemens SOMATOM Scope Recalled for Potential Unnecessary Radiation Exposure
Siemens Medical Solutions is recalling SOMATOM Scope devices due to a software issue that may cause unnecessary radiation exposure.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of harm (unnecessary radiation exposure) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling SOMATOM Scope devices (Model 10967666) because of a software issue. The defect presents a potential risk of unnecessary radiation exposure to patients.
The recall is classified as Class II by the U.S. Food and Drug Administration. The affected units were distributed nationwide. Specific serial numbers for the recalled devices are listed in the official recall notice.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the software issue and ensure patient safety.
The recalled product
- Product
- SOMATOM Scope ( Model 10967666)
- Manufacturer
- Siemens Medical Solutions USA, Inc
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 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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