Product Wiki · Recalls · U.S. FDA — Device Enforcement

Merge FlexConnect software, a component of Merge LIS — recall Z-0664-2017

U.S. FDA — Device Enforcement · United States · 2016-01-30 · Class II

As described by U.S. FDA — Device Enforcement: Merge FlexConnect software, a component of Merge LIS. Merge FlexConnect is middleware used in conjunction with Merge LIS to facilitate connection to external applications

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0664-2017
Date of alert
2016-01-30
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Merge Healthcare, Inc.
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Nationwide Distribution
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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