Z-0664-2017Class II

Merge FlexConnect software, a component of Merge LIS. Merge FlexConnect is middleware used in conjunction...

Name: Z-0664-2017 Merge FlexConnect software, a component of Merge LIS. Merge FlexConnect is middleware used in conjunction...
Creator: Merge Healthcare, Inc.
Published: 2016-01-30
License: https://open.fda.gov/license/

Merge Healthcare Incorporated / initiated 2016-01-30 / Terminated / root cause: software

FDA source

Merge Healthcare, Inc. began a recall of Merge FlexConnect software, a component of Merge LIS. Merge FlexConnect is middleware used in conjunction with Merge LIS to facilitate connection to external... on 2016-01-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0664-2017
Classification: Class II
Status: Terminated
Initiated: 2016-01-30
Posted: 2016-11-28
Terminated: 2019-03-20
Recalling firm: Merge Healthcare Incorporated
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
Product code: OUG Medical Device Data System
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.
Root cause tag: software
FDA root cause: Software design
Action: The recalling firm issued a letter dated 1/27/2016 via e-mail on 1/30/2016. Nonresponders were issued a second letter dated 5/25/2016 via email on 5/26/2016.
Quantity in commerce: 324 sites potentially have the affected version
Distribution: Nationwide Distribution
Product codes and lots: Version 1.0

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0664-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0664-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-07	2016-11-28

Product code OUG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)