Siemens Syngo Imaging Software Recall for Version VB36D_HF02
Siemens Medical Solutions is recalling three units of Syngo Imaging software to provide supplementary information regarding the release of Version VB36D_HF02.
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 is described as providing supplementary information for a software release with no reported injuries or illnesses, fitting the criteria for a voluntary precautionary recall.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling three units of the Syngo Imaging VB36D_HF02 radiological image processing system. The recall involves software models 10014063 and 10014064. The agency classifies this as a Class II recall.
The recall is initiated to provide supplementary information regarding the release of the syngo Imaging Software Version VB36D_HF02. The software provides improvements for all syngo Imaging installations running on the software Version VB36D.
The affected units were distributed to the states of North Carolina, Nebraska, and Ohio. No specific instructions for consumers are provided in the source text.
The recalled product
- Product
- Syngo Imaging VB36D_HF02. Radiological image processing system.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — Software
- Hazard
- Affected units
- 3
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# 10014063 and 10014064
Distribution
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