Siemens SOMATOM go.Now CT Scanner Recall for Workflow Interruptions
Siemens Medical Solutions is recalling 53 SOMATOM go.Now CT scanners due to potential sporadic performance problems that may cause scanning workflow interruptions and delays in diagnosis.
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. The hazard involves workflow interruptions and delays in diagnosis rather than direct physical injury or death, fitting the criteria for moderate severity.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 53 units of the SOMATOM go.Now computed tomography (CT) system (Model #11061620) equipped with syngo.CT software versions VA20A, VA20A_SP0, or VA20_SP1. The recall is due to potential sporadic performance problems that may result in scanning workflow interruptions and unexpected user notifications.
These performance issues may cause a delay in diagnosis or patient scans. The affected units were distributed nationwide in the United States, including in 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 identify affected units by checking the serial numbers listed in the recall notice. Siemens Medical Solutions USA, Inc. is the recalling firm responsible for addressing these performance issues.
The recalled product
- Product
- SOMATOM go.Now (Model #11061620), 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
- 53
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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