Siemens syngo X Workplace Medical Workstation Recalled for Segmentation Error
Siemens Medical Solutions USA is recalling six syngo X Workplace medical workstations because imported segmentation results appear mirrored, rendering them unusable for ablation procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 a functional software error that renders the device unusable for a specific procedure rather than a defect causing injury or death. No injuries or illnesses are reported, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling six units of the syngo X Workplace medical workstation. This device is used for real-time viewing, image manipulation, 3D-visualization, communication, and storage of medical images and data, specifically for diagnostic image viewing and post-processing during interventional procedures.
The recall was initiated because, after importing data, the segmentation results appear mirrored at the CARTO system. This error prevents the results from being used for the ablation procedure. The affected units were distributed nationwide to Illinois, New York, Montana, and Minnesota.
The affected serial numbers are 20119, 20098, 20041, 20124, 12177, and 20026. Healthcare facilities and users should contact Siemens Medical Solutions USA, Inc. for instructions on how to resolve the issue or replace the affected units.
The recalled product
- Product
- syngo X Workplace is a medical workstation for real-time viewing, image manipulation, 3D-visualization, communication, and storage of medical images and data on exchange media. It is used for diagnostic image viewing and post processing during interventional procedures. .
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 6
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 (6)
- Serial # 20119
- 20098
- 20041
- 20124
- 12177
- 20026
Distribution
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