Siemens CT System Recalled for Potential Scanning Workflow Interruptions
Siemens Medical Solutions is recalling 69 SOMATOM go.Top CT systems due to potential sporadic performance problems that may cause diagnostic delays or the need for 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, and the source text describes performance issues leading to workflow interruptions and diagnostic delays without reporting any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 69 units of the SOMATOM go.Top computed tomography (CT) system, Model No. 11061648, equipped with syngo.CT software versions VA20A, VA20A_SP0, or VA20_SP1. The recall is being conducted by the U.S. Food and Drug Administration (FDA) under recall number Z-1922-2019.
The recall is issued because the devices may experience potential sporadic performance problems. These issues can result in scanning workflow interruptions and unexpected user notifications. Consequently, patients may experience diagnostic delays or may require a rescan.
The affected units were distributed nationwide in the United States, specifically in the states of Alabama, California, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Michigan, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New York, Ohio, Oklahoma, South Dakota, Tennessee, Texas, Virginia, and Wisconsin. Healthcare facilities using these systems should contact Siemens Medical Solutions USA, Inc. for further instructions on resolving the performance issues.
The recalled product
- Product
- SOMATOM go.Top, Model No. 11061648 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 imag
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 69
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)
- 119913
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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