Siemens syngo.plaza Radiological Image Processing System Software Update Recall
Siemens Medical Solutions USA, Inc. is recalling 15 syngo.plaza systems to address unintended software behavior that may affect system performance.
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, but the source text describes a software performance issue (log filling) without reporting any patient injuries, deaths, or significant adverse health consequences, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 15 units of the syngo.plaza Radiological Image Processing System (Model number 10 592 457). The firm issued an Update Instruction (SY050/12/S) to provide a software update that addresses unintended behavior in the system.
The recall is due to a software issue where patient rename messages for the same patient are continually processed for several days. This behavior fills up the 'pcvdbsrv' log and potentially affects the performance of the system. The source text notes that data could be affected, though specific details regarding data loss or corruption are not fully detailed in the provided excerpt.
The affected units were distributed nationwide in the United States, including the states of California, Florida, Georgia, Massachusetts, Minnesota, Missouri, New Jersey, New York, Ohio, and Wisconsin. Users of these systems should contact Siemens Medical Solutions USA, Inc. to obtain and install the software update.
The recalled product
- Product
- Siemens syngo.plaza Radiological Image Processing System Usage: Radiological Image Processing System
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 15
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)
- Model number 10 592 457
Distribution
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