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Recall Observatory FDA recall evidence

Device product

Syngo Imaging VB36D_HF02. Radiological image processing system.

Z-0319-2016

October 28, 2015

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 72576
Status
Terminated
Classification
Class II
Quantity
3
Official record key
device-enforcement:Z-0319-2016

Official wording

Reason: To provide supplementary information regarding the release of the syngo Imaging Software Version VB36D_HF02. The software provides improvements for all syngo Imaging installations running on the software Version VB36D.

Code information: model# 10014063 and 10014064

Distribution pattern: US Distribution to the states of : NC, NE and OH.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    To provide supplementary information regarding the release of the syngo Imaging Software Version VB36D_HF02. The software provides improvements for all syngo Imaging installations running on the software Version VB36D.