Siemens SOMATOM go.Top CT Systems Recalled for Missing Dose Documentation
Siemens is recalling 14 SOMATOM go.Top CT systems in seven states because they fail to document radiation dose or issue alerts during specific interventional procedures.
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 where a lack of dose documentation and alerts poses a risk of harm (excessive radiation exposure) to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 14 units of the SOMATOM go.Top computer tomography x-ray system, specifically Models 11061640 and 11061648. The affected units are equipped with software syngo CT VA20A_SP2 and an active Guide&GO license. These systems are distributed in the United States in the states of Georgia, Indiana, Missouri, Mississippi, New Jersey, Ohio, and Pennsylvania.
The recall is due to a software defect where the system does not provide dose documentation and does not issue a Dose Alert when the special mode i-Sequence is used during interventional procedures. This lack of documentation and alerting may prevent healthcare providers from accurately tracking radiation exposure to patients during these specific procedures.
Healthcare facilities that have these specific models and software configurations should contact Siemens Medical Solutions USA, Inc. for instructions on how to resolve the issue. Patients who have undergone interventional procedures using the i-Sequence mode on these systems may wish to consult their healthcare provider regarding their radiation exposure history.
The recalled product
- Product
- SOMATOM go.Top, Models 11061640 & 11061648- a Computer tomography x-ray system
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 14
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)
- software syngo CT VA20A_SP2 and active Guide&GO license
Distribution
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