Siemens Recalls Syngo Plaza PACS Software Due to Display and Access Issues
Siemens is recalling 68 units of Syngo Plaza PACS software to fix bugs affecting image display, saving, and access controls.
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 describes software functionality issues without reporting any illnesses, injuries, or fatalities, fitting the criteria for a moderate severity score.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 68 units of the Syngo Plaza Picture archiving and communication system (PACS) software. The affected software is intended to display, process, read, report, communicate, distribute, store, and archive digital medical images. The recall covers device model numbers 10863171, 10863172, and 10863173.
The recall is being conducted to address several software issues. These issues include RGB images displaying a "?" symbol because the calculation of Hounsfield Units (HU) is not possible, the "save as" option being enabled, changes in access for loading studies, and the breast region not properly fitting to the segment boundary when the "fit breast to screen" function is used.
The affected software was distributed nationwide, including in Alabama, California, Connecticut, Florida, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Nebraska, New York, Ohio, Oregon, Pennsylvania, Texas, Washington, and Wisconsin. Siemens is releasing an updated software version to resolve these issues.
The recalled product
- Product
- Syngo Plaza Picture archiving and communication system. Software only. PACS intended to display, process, read, report, communicate, distribute, store and archive digital medical images. Stores and archives within DICOM structured reports. Integrates hospital/radiology…
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — Software
- Hazard
- Affected units
- 68
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 (3)
- Device model numbers: 10863171
- 10863172
- 10863173
Distribution
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