Siemens syngo.plaza Radiological Image Processing System Recalled for Miscalculation
Siemens Medical Solutions is recalling 14 syngo.plaza systems due to a potential miscalculation in images with pixel depth values greater than 12 bits.
What this means for you
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 does not report any hospitalizations, injuries, or deaths, and the hazard is a software miscalculation rather than a direct physical injury risk.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 14 units of the syngo.plaza radiological image processing system, Model number 10592457. The recall is due to a potential malfunction where a miscalculation occurs for images with pixel depth values greater than 12 bits in certain functions.
The affected units were distributed nationwide to facilities in California, Florida, Georgia, Massachusetts, Minnesota, Missouri, New Jersey, New York, Ohio, Washington, and Wisconsin. The specific serial numbers for the recalled units are 100263, 100401, 100177, 100138, 100174, 100219, 100406, 100249, 200040, 100201, 100198, 100181, 100301, and 100146.
The FDA has classified this as a Class II recall. No specific instructions for consumers are provided in the source text, but the recall is limited to the specific serial numbers listed above.
The recalled product
- Product
- syngo.plaza, Model number 10592457. Intended use: radiological image processing system.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 14
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 (14)
- Serial Numbers: 100263
- 100401
- 100177
- 100138
- 100174
- 100219
- 100406
- 100249
- 200040
- 100201
- 100198
- 100181
- 100301
- & 100146.
Distribution
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