Siemens Medical Software Recall for Missing Image Measurements on Printouts
Siemens Medical Solutions is recalling 167 units of Syngo.via and Syngo.x software because measurements on subsequent images do not appear on printouts.
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, which typically corresponds to a moderate severity level where the product could cause temporary or medically reversible health consequences. No specific injuries or illnesses are reported in the source text.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 167 units of Syngo.via and Syngo.x software. This software is intended for viewing, manipulating, communicating, and storing medical images. The recall is due to a defect where measurements drawn on the second and subsequent images of a series are not visible on printouts when the series is sent to print.
The affected software is identified by model number 10496180 and specific serial numbers listed in the recall documentation. The recall is classified as Class II by the FDA, indicating a situation where use of the product could cause temporary or medically reversible health consequences.
Healthcare facilities and users of the affected software should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address the issue. The recall is distributed nationwide.
The recalled product
- Product
- Syngo.via and Syngo.x ; a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 167
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)
- Model Number of device: 10496180
Distribution
Distributed nationwide across the United States.
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