Merge FlexConnect Software Recalled for Data Processing Errors
Merge Healthcare is recalling Merge FlexConnect software version 1.0 because communication protocols were not properly handled, preventing data from being processed by the LIS software.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any hospitalizations, significant injuries, or property damage, fitting the criteria for a moderate severity score.
Plain-English summary
Merge Healthcare, Inc. is recalling Merge FlexConnect software, version 1.0. This software is a component of Merge LIS and serves as middleware to facilitate connections to external applications. The recall affects 324 sites nationwide that potentially have the affected version.
The recall was initiated because communication protocols interfacing with the affected software version and some select instruments were not properly handled. This issue prevented data captured by these instruments from being processed by the rest of the LIS software.
The source text does not specify specific actions for consumers or end-users, nor does it report any illnesses or injuries associated with this software defect.
The recalled product
- 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
- Manufacturer
- Merge Healthcare, Inc.
- Category
- Medical Device — Software
- Hazard
- Affected units
- 324
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Version 1.0
Distribution
Distributed nationwide across the United States.
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