Siemens Syngo.via Software Recall for Medical Image System Issues
Siemens Medical Solutions is recalling 104 units of Syngo.via picture archiving software to address several identified issues.
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, and the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 104 units of the Syngo.via picture archiving and communication system. This software solution is used in healthcare institutions for viewing, manipulating, communicating, and storing medical images in environments such as Radiology, Nuclear Medicine, and Cardiology.
The recall is being conducted to address several issues identified in the software. The source text indicates that software changes are now available to resolve these problems. The affected units were distributed nationwide.
Healthcare facilities using this software should contact Siemens Medical Solutions USA, Inc. for information regarding the available software updates. The specific nature of the issues is not detailed in the provided source text.
The recalled product
- Product
- Syngo.via, Picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmodified syngo…
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — Software
- Hazard
- Affected units
- 104
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 (2)
- Device Model Numbers: 10863171
- 10863172
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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