Siemens Syngo.plaza PACS Systems Recalled for Software Update Issues
Siemens Medical Solutions is recalling 13 Syngo.plaza PACS systems nationwide due to software update issues. The recall is voluntary and has been terminated.
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 is a voluntary, firm-initiated action for software updates. The source text does not report any injuries, illnesses, or specific safety hazards, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Siemens Medical Solutions USA, Inc. is voluntarily recalling 13 units of the Syngo.plaza Picture Archiving and Communications System (PACS). The recall was initiated on February 20, 2017, and was terminated on August 7, 2017. The reason for the recall is cited as software updates.
The affected devices are distributed nationwide to Missouri, Texas, Florida, Massachusetts, Wisconsin, Pennsylvania, Indiana, and California. The specific model numbers are 10863171 and 10863173, with serial numbers ranging from 100212 to 100484 as listed in the recall documentation.
This recall is classified as Class II by the FDA. The firm notified customers via letter. No specific injuries or illnesses are reported in the source text.
The recalled product
- Product
- Syngo.plaza, Picture Archiving and Communications System (PACS) 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 physician in…
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 13
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)
- Device Model Number: 10863171
Distribution
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