Siemens Recalls Syngo Imaging Software Due to Display and Measurement Errors
Siemens is recalling Syngo Imaging software versions V30 and V31 because safety issues may occur involving monitor assignment order and incorrect display and measurements for images with non-square pixel size.
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 is classified as FDA Class II and involves a risk-of-harm product where injury has not yet been reported, meeting the criteria for a High severity score.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling Syngo Imaging software, versions V30 and V31. Syngo Imaging is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store, and archive digital medical images, including digital mammography images.
The recall is being conducted because during certain clinical workflows, safety issues may occur involving monitor assignment order and incorrect display and measurements for images with non-square pixel size.
The recall affects five units distributed in the United States in the states of North Carolina and Nebraska. The affected units have model number 10014064 and serial numbers 5846, 5847, 4333, 4334, and 4335.
The recalled product
- Product
- SYNGO IMAGING (VERSION V30 and V31); Syngo Imaging is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — Software
- Affected units
- 5
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: 10014064 serial numbers: 5846 5847 4333 4334 4335
Distribution
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