Merge FlexConnect software — Class II medical device recall Z-0664-2017
Terminated recall by Merge Healthcare, Inc., reported 2016-12-07, distributed nationwide. Communication protocols interfacing with the affected software version with some select instruments were not p
| Recall number | Z-0664-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merge Healthcare, Inc., Hartland, WI, United States |
| Recall initiated | 2016-01-30 |
| Classified | 2016-11-28 |
| Reported by FDA | 2016-12-07 |
| Terminated | 2019-03-20 |
| Distributed | Nationwide (US) |
| Quantity | 324 sites |
| Reason classes | software |
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0664-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.