Siemens Syngo Dynamics PACS Software Recall for Workflow Error
Siemens is recalling 84 units of Syngo Dynamics software due to a defect that may cause old measurements to be carried forward into new reports.
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 the hazard involves a risk of harm (incorrect medical analysis) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 84 units of the Syngo Dynamics; Kinetdx Picture Archiving and Communications System. The recall affects specific model and serial numbers distributed nationwide across 18 states, including Arizona, California, Illinois, Indiana, Massachusetts, Maryland, Michigan, Minnesota, New Jersey, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Washington, and Wisconsin.
The recall was initiated because Siemens identified changes in the default carry forward workflow using the VA10B_HF03 version of the software. If a template design includes measurements inside a carry forward-configured report section, the system may carry forward the entire section, including data from previous studies. This defect may result in physicians making analysis based on old measurements rather than current data.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to resolve the issue. The source text does not specify a particular action for consumers, as this is a medical device software recall affecting professional healthcare settings.
The recalled product
- Product
- Syngo Dynamics; Kinetdx Picture Archiving and Communications System
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — Software
- Affected units
- 84
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)
- Model Numbers: 10091637
- 10091673
- 10091805
- 10091807 Serial Numbers: 85021
- 85040
- 85042
- 85045
- 85047
- 85057
- 85079
- 85080
- 85081
- 85086
- 85090
- 85115
- 85143
- 85145
- 85146
- 85147
- 85149
Distribution
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