Siemens SOMATOM go.All CT Systems Recalled for Performance Issues
Siemens is recalling 24 SOMATOM go.All CT systems due to sporadic performance problems that may interrupt scanning workflows and delay diagnoses.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes potential workflow interruptions and delays in diagnosis without reporting any specific injuries, illnesses, or fatalities.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 24 units of the SOMATOM go.All (Model #11061630) computed tomography (CT) system. The affected units are equipped with syngo.CT software versions VA20A, VA20A_SP0, or VA20_SP1. These systems are intended to generate and process cross-sectional images of patients for diagnostic and treatment planning purposes.
The recall is being conducted because the devices may experience sporadic performance problems. These issues can result in scanning workflow interruptions and unexpected user notifications. Such interruptions may cause delays in patient scans or diagnoses.
The affected units were distributed nationwide in the United States, including in Alaska, Alabama, Arizona, California, Colorado, Connecticut, the District of Columbia, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Texas, Virginia, Washington, Wisconsin, and Puerto Rico. Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for further instructions regarding the recall.
The recalled product
- Product
- SOMATOM go.All (Model #11061630), with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images d
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 24
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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