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Recall Observatory FDA recall evidence

Device product

Merge FlexConnect software, a component of Merge LIS. Merge FlexConnect is middleware used in conjunction with Merge LIS to facilitate connection to external applications

Z-0664-2017

January 30, 2016

Class II

Product summary

Firm
Merge Healthcare, Inc.
Event
Event 75334
Status
Terminated
Classification
Class II
Quantity
324 sites potentially have the affected version
Official record key
device-enforcement:Z-0664-2017

Official wording

Reason: Communication protocols interfacing with the affected software version with some select instruments were not properly handled, preventing data captured by these instructions to be processed by the rest of the LIS software.

Code information: Version 1.0

Distribution pattern: Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Communication protocols interfacing with the affected software version with some select instruments were not properly handled, preventing data captured by these instructions to be processed by the rest of the LIS software.