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Recall Observatory FDA recall evidence

Device product

syngo Dynamics Picture Archiving and Communication System (PACS). Model numbers 10091804, 10091805, 10091806, 10091807, 10091673

Z-1216-2014

January 27, 2014

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 67559
Status
Terminated
Classification
Class II
Quantity
50
Official record key
device-enforcement:Z-1216-2014

Official wording

Reason: 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.

Code information: Model nos.10091804, 10091805, 10091806, 10091807, 10091673. syngo Dynamics Version 9.5 using Sensis integration.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.