Siemens syngo Dynamics PACS Recalled for Potential Patient Data Mixup
Siemens is recalling 50 syngo Dynamics PACS units because improper error handling could display images for one patient and reports for another, risking misdiagnosis.
What this means for you
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 risk-of-harm product (medical device) where injury or misdiagnosis has not yet been reported, fitting the 'High' severity criteria for theoretical hazards without confirmed adverse events.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 50 units of the syngo Dynamics Picture Archiving and Communication System (PACS). The affected model numbers are 10091804, 10091805, 10091806, 10091807, and 10091673, specifically those using syngo Dynamics Version 9.5 with Sensis integration.
The recall was initiated due to improper error handling that could allow data for two different patients to be displayed simultaneously. This defect may result in medical images for one patient being shown alongside the reporting system for a different patient, creating a potential for misdiagnosis.
The units were distributed nationwide to facilities in Minnesota, Arkansas, Massachusetts, Texas, New Jersey, West Virginia, Georgia, California, Pennsylvania, Ohio, Michigan, Wisconsin, Tennessee, New York, Kansas, Connecticut, Missouri, Illinois, Indiana, Oregon, Iowa, and Washington. Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the software defect.
The recalled product
- Product
- syngo Dynamics Picture Archiving and Communication System (PACS). Model numbers 10091804, 10091805, 10091806, 10091807, 10091673
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- 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 (5)
- Model nos.10091804
- 10091805
- 10091806
- 10091807
- 10091673. syngo Dynamics Version 9.5 using Sensis integration.
Distribution
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