Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2245-2016·Announced 2016-07-27

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.

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. 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: incorrect-data
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

Distributed nationwide across the United States.

The notice also names 29 states specifically:

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