Siemens Recalls CT Scanner Software for Radiation Risk
Siemens Medical Solutions is recalling 134 SOMATOM Definition Edge CT scanners 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 medical device with a potential risk of harm (unnecessary radiation exposure) where injury has not yet been reported. The agency classification is FDA Class II, which aligns with the 'High' severity criteria for risk-of-harm products without reported illness.
Plain-English summary
Siemens Medical Solutions USA, Inc. has initiated a recall of the SOMATOM Definition Edge (Model 10590000) Computed tomography x-ray diagnostic system. The company is recalling 134 units distributed across all 50 U.S. states, the District of Columbia, Guam, and Puerto Rico.
The recall addresses a potential risk of unnecessary radiation exposure. This risk stems from a software issue found in the CARE Dose4D algorithm implemented in specific Siemens Healthineers CT scanners, including the SOMATOM Definition Edge. The affected serial numbers are listed in the official recall notice.
Consumers and healthcare providers should consult the official FDA recall page for further details on how to verify if a specific unit is affected and what corrective actions are required.
The recalled product
- Product
- SOMATOM Definition Edge (Model 10590000) Computed tomography x-ray diagnostic system
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 134
Distribution
Part of a larger recall action
This product is one of 4 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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