Siemens Recalls Syngo.plaza PACS Software Due to Image Count Discrepancy
Siemens Medical Solutions is releasing a software tool to fix an issue where Syngo.plaza PACS displays fewer de-archived images than archived.
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: This is a Class II recall involving a software defect that affects data integrity (image counts) but does not pose a direct risk of serious injury or death, fitting the criteria for a moderate severity precautionary software fix.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling two units of the Syngo.plaza Picture Archiving and Communications System (PACS), Model 10863171. The recall involves a non-medical software application, the LTA Incomplete Archive Check Tool V1.0, which is intended to resolve a specific data integrity issue.
The issue occurs during the de-archiving process from Digital Long-Term Archive (Dicom LTA). It was identified that the number of de-archived images could be less than the count of the originally archived images for a given series. These issues were discovered through Siemens' Global Complaint Handling System.
The affected units were distributed to Minnesota. Siemens is releasing the check tool to eliminate this discrepancy. Users should apply the software update to ensure accurate image counts during de-archiving.
The recalled product
- Product
- Syngo.plaza, Picture Archiving and Communications System(PACS), Model 10863171 Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the…
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — Software
- Affected units
- 2
Distribution
Distributed in 1 state:
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