Siemens Syngo.via software recall due to data archiving configuration error
Siemens is recalling 165 units of Syngo.via software because a software upgrade disabled a data cleanup function, causing incorrect archiving flags and reduced disk capacity.
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. The hazard involves data management and disk capacity issues rather than direct physical injury or a high-risk pathogen, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 165 units of Syngo.via software, model number 10496180, with VB20A. The software is used for viewing, manipulating, communicating, and storing medical images. The recall is due to a defect where the automatic function for cleaning up temporary data is disabled by a software upgrade.
When the archiving configuration is changed, data received or created after the upgrade may be incorrectly flagged as "Not to be archived." Because the cleanup function is disabled, disk capacity for free space decreases faster than usual. If the archiving configuration and cleanup function are not reverted to their original state, clinical administrators or service engineers must manually prevent the incorrectly flagged data from being deleted.
The affected units are medical device software systems that require installation. Siemens is the recalling firm. The source text does not specify a distribution geography or report any illnesses or injuries.
The recalled product
- Product
- Syngo.via software is 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 based software options.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — Software
- Hazard
- Affected units
- 165
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)
- All Syngo.via systems with VB20A. Model number 10496180.
Distribution
Distribution scope not specified by the agency.
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