Siemens SOMATOM go.Up CT Systems Recalled for Performance Issues
Siemens is recalling 69 SOMATOM go.Up CT systems due to sporadic performance problems that may cause diagnostic delays or patient rescans.
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 explicitly states the hazard is a performance issue causing workflow interruptions and diagnostic delays, with no reported injuries or illnesses. This aligns with the 'Moderate' criteria for low-risk issues or voluntary precautionary measures where harm is not yet reported.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 69 units of the SOMATOM go.Up computed tomography (CT) system, Model No. 11061628, equipped with syngo.CT software versions VA20A, VA20A_SP0, or VA20_SP1. The affected units were distributed nationwide in the United States, specifically in the states of AL, CA, CT, FL, GA, IL, IN, KS, KY, LA, ME, MI, MO, MS, NC, ND, NE, NH, NY, OH, OK, SD, TN, TX, VA, and WI.
The recall is being issued due to potential sporadic performance problems. These issues may cause scanning workflow interruptions and unexpected user notifications, which can result in diagnostic delays or the need for patients to be rescanned. The source text does not report any injuries, illnesses, or deaths associated with this recall.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address the performance issues on their equipment. Patients who have had scans on these systems should consult their healthcare providers if they have concerns about their diagnostic results.
The recalled product
- Product
- SOMATOM go.Up, Model No. 11061628 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 image
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 69
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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