Siemens SOMATOM Scope Power Recalled for Software Radiation Risk
Siemens is recalling SOMATOM Scope Power units due to a software issue that may cause unnecessary radiation exposure.
What this means for you
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 involves a risk of harm (unnecessary radiation exposure) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling the SOMATOM Scope Power (Model 10967888) medical device. The recall is being conducted because of a software issue that creates a potential risk of unnecessary radiation exposure.
The affected units are distributed nationwide. The recall covers specific serial numbers listed in the official agency documentation. No specific number of affected units or reported injuries is provided in the source text.
Consumers and 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 Power (Model 10967888)
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
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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