Siemens SOMATOM go.Top CT Systems Recalled for Performance Issues
Siemens Medical Solutions is recalling 30 SOMATOM go.Top CT systems due to potential performance problems that may interrupt scanning workflows and delay patient 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, but the source text describes only workflow interruptions and delays in diagnosis without reporting any injuries, illnesses, or structural defects, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 30 units of the SOMATOM go.Top (Model #1161640) 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 to aid in diagnosis, treatment preparation, and radiation therapy planning.
The recall is being issued because the devices may experience potential sporadic performance problems. These issues can result in scanning workflow interruptions and unexpected user notifications, which may cause delays in diagnosis or patient scans. The recall is classified as Class II by the FDA.
The affected units were distributed nationwide in the United States, including the states of AK, AL, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, PA, SC, TX, VA, WA, WI, and Puerto Rico. Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for further instructions on resolving the performance issues.
The recalled product
- Product
- SOMATOM go.Top (Model #1161640), 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 de
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 30
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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