FDA-Device2016-12-07Class II
Merge FlexConnect software, a component of Merge LIS. Merge FlexConnect is middleware used in conjunction with Merge LIS to facilitate connection to external applications
Merge Healthcare, Inc.
Hazard
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.
Sold states
Nationwide Distribution
Affected count
324 sites potentially have the affected version
Manufactured in
900 Walnut Ridge Dr, Hartland, WI, United States
Products
Merge FlexConnect software, a component of Merge LIS. Merge FlexConnect is middleware used in conjunction with Merge LIS to facilitate connection to external applications
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0664-2017Don't want to check this manually?
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