Siemens Syngo.via PACS Software Recalled for Incorrect Volume Calculations
Siemens Medical Solutions is recalling 50 units of Syngo.via PACS software due to incorrect volume calculation values. A software update is available to resolve the error.
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. The hazard involves incorrect data calculation rather than a direct physical injury mechanism, and no injuries or illnesses are reported, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 50 units of Syngo.via, a picture archiving and communications system (PACS) software controlled product. The software is intended for the viewing, manipulation, communication, and storage of medical images. The recall is being conducted because the software produces incorrect values for volume calculations.
The affected units were distributed nationwide to facilities in Arkansas, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, and Utah. Specific lot or serial codes are listed in the agency's structured data, but no specific dates of distribution or installation are provided in the source text.
To resolve the software errors, Siemens has issued software update VB30B. Users should follow Update Instructions SY018/16/P to apply the necessary fix. No illnesses, injuries, or deaths are reported in the source text.
The recalled product
- Product
- Syngo.via, picture archiving and communications system software controlled. Intended to be used for viewing, manipulation, communication, and storage of medical images.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — Software
- Hazard
- Affected units
- 50
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 (20)
- 310289
- 130542
- 130322
- 310149
- 130325
- 221063
- 310168
- 101762
- 221048
- 221096
- 220783
- 310195
- 130451
- 400031
- 130292
- 310114
- 220846
- 130269
- 130163
- 130402
Distribution
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