FDA-Device2014-03-26Class II
syngo Dynamics Picture Archiving and Communication System (PACS). Model numbers 10091804, 10091805, 10091806, 10091807, 10091673
Siemens Medical Solutions USA, Inc
Hazard
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.
Sold states
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.
Affected count
50
Manufactured in
51 Valley Stream Pkwy, Malvern, PA, United States
Products
syngo Dynamics Picture Archiving and Communication System (PACS). Model numbers 10091804, 10091805, 10091806, 10091807, 10091673
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1216-2014Don't want to check this manually?
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