Siemens Syngo.x Software Recalled for Incorrect Volume Calculations
Siemens Medical Solutions is recalling 338 Syngo.x PACS systems because a software error caused volume calculations for prostate and liver to be too high.
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 is a software error leading to inaccurate diagnostic data (volume overestimation) without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 338 units of the Syngo.x picture archiving and communication system (PACS). This software solution is intended for the viewing, manipulation, communication, and storage of medical images. The recall is due to a software error that resulted in incorrect values for volume calculations using a freehand volume of interest (VOI) at customer sites.
The specific defect involves volume calculations for the prostate and liver, which were calculated to be too high. The affected systems were distributed nationwide. The source text does not report any illnesses, injuries, or deaths associated with this software error.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. to determine if their systems are affected and to obtain the necessary software updates or corrections. Consumers are not directly affected as this is a professional medical device used in clinical settings.
The recalled product
- Product
- Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — Software
- Affected units
- 338
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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