Merge FlexConnect software, a component of Merge LIS. Merge FlexConnect is middleware used in conjunction with Merge LIS to facilitate connection to external applications
Reported: December 7, 2016 Initiated: January 30, 2016 #Z-0664-2017
Product Description
Merge FlexConnect software, a component of Merge LIS. Merge FlexConnect is middleware used in conjunction with Merge LIS to facilitate connection to external applications
Reason for Recall
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.
Details
- Recalling Firm
- Merge Healthcare, Inc.
- Units Affected
- 324 sites potentially have the affected version
- Distribution
- Nationwide Distribution
- Location
- Hartland, WI
Frequently Asked Questions
What product was recalled? ▼
Merge FlexConnect software, a component of Merge LIS. Merge FlexConnect is middleware used in conjunction with Merge LIS to facilitate connection to external applications. Recalled by Merge Healthcare, Inc.. Units affected: 324 sites potentially have the affected version.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 7, 2016. Severity: Moderate. Recall number: Z-0664-2017.
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