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Recall Observatory FDA recall evidence

Device product

Syngo.via. Medical Device Software. Picture archiving and communications system.

Z-1303-2018

January 08, 2018

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 79532
Status
Terminated
Classification
Class II
Quantity
236 units
Official record key
device-enforcement:Z-1303-2018

Official wording

Reason: A software functionality in the report sections Findings Information and Summary of Measured Findings is not performing properly. The system will use the original values instead of displaying and saving corrected/modified values. Outdated information could be sent to the referring physician when creating the formal report in the reporting system.

Code information: Model Number 10496180

Distribution pattern: Device is software only. No products are distributed to wholesale dealers, distributers or retailers

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    A software functionality in the report sections Findings Information and Summary of Measured Findings is not performing properly. The system will use the original values instead of displaying and saving corrected/modified values. Outdated information could be sent to the referring physician when creating the formal report in the reporting system.