Siemens syngo.plaza Radiological Image Processing System Recall
Siemens is recalling 11 syngo.plaza systems due to a software defect where archived studies may be missing from the database.
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 a software data integrity issue without reporting any patient injuries, illnesses, or deaths, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 11 units of the syngo.plaza radiological image processing system. The recall is due to an unintended behavior in the software's online "Short Time Storage" (STS) feature.
The issue involves studies that are marked with an archived icon in the interface, but the corresponding entry in the Archive Database referring to the physical file may be missing. This defect affects the integrity of the data storage and retrieval process for these specific studies.
The affected units were distributed nationwide, including in Missouri, Florida, Massachusetts, New York, Wisconsin, Georgia, California, and Washington. The specific model number is 10592457, and the affected serial numbers are 100263, 100401, 100177, 100138, 100174, 100406, 100249, 100201, 100198, 100181, and 100146. Users should contact Siemens Medical Solutions USA, Inc. for further instructions on how to resolve the software defect.
The recalled product
- Product
- Siemens syngo.plaza radiological image processing system.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 11
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 (12)
- Model number 10592457
- serial numbers 100263
- 100401
- 100177
- 100138
- 100174
- 100406
- 100249
- 100201
- 100198
- 100181
- 100146.
Distribution
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