Siemens syngo Imaging XS Software Recall for Potential Miscalculation
Siemens is recalling syngo Imaging XS software due to potential miscalculation of grey scale values in specific image processing functions.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device software malfunction that could impact diagnostic accuracy, representing a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 141 units of syngo Imaging XS software, version VA70A or higher. The software is a Picture Archiving and Communication System (PACS) used to display, process, and store digital medical images to support physician diagnosis and treatment planning.
The recall is due to a potential malfunction where miscalculation may occur for grey scale values in the Region of Interest, Pixel Lens, Edge enhancement, and Histograms functions. This issue may affect images with a pixel depth greater than 12 bits.
The affected software was distributed nationwide. Users of the affected software should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address the potential malfunction.
The recalled product
- Product
- Siemens syngo Imaging XS, version VA70A or higher Syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and…
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — Software
- Affected units
- 141
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 (1)
- model number: 10496279
Distribution
Distributed nationwide across the United States.
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