syngo Dynamics Picture Archiving and Communication recall
syngo Dynamics Picture Archiving and Communication System (PACS). Model numbers 10091804, 10091805, 10091806, 10091807, 10091673
Why was syngo Dynamics Picture Archiving and Communication recalled?
Potential patient data mixup. Improper error handling could allow for two different patients to be displayed in syngo Dynamics. Images shown for one patient and reporting system shown for a different patient, leading to the potential for misdiagnosis.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model nos.10091804, 10091805, 10091806, 10091807, 10091673. syngo Dynamics Version 9.5 using Sensis integration.
- Product
- syngo Dynamics Picture Archiving and Communication System (PACS). Model numbers 10091804, 10091805, 10091806, 10091807, 10091673
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 50
- Distribution
- Nationwide distribution to MN, AR, MA, TX, NJ, WV, GA, CA, PA, OH, MI, WI, TN, NY, KS, CT, NY, MO, IL, IN, OR, IA, and WA.
- Recall date
- March 26, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)