Merge Healthcare iConnect Enterprise Archive Software Recall for Routing Errors
Merge Healthcare is recalling iConnect Enterprise Archive software versions 5.30.0 through 9.4.3 and V11.0 because routing exceptions may delay diagnosis or treatment.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device software defect that may result in potential patient injury or delay in diagnosis or treatment, fitting the High severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Merge Healthcare, Inc. is recalling iConnect Enterprise Archive software when used with RadSuite. The affected software versions are 5.30.0 through 9.4.3 and V11.0. The firm name on the label is Merge Healthcare.
The recall was initiated because the software produced a number of "do not route" exceptions. These exceptions may result in potential patient injury or delay in diagnosis or treatment.
The affected software was distributed nationwide in the United States to medical facilities and through government distribution. There was no foreign or military distribution. Approximately 187 sites potentially have the affected versions. Users should contact Merge Healthcare for further instructions on how to address the software issue.
The recalled product
- Product
- iConnect Enterprise Archive when used with RadSuite. The firm name on the label is Merge Healthcare.
- Manufacturer
- Merge Healthcare, Inc.
- Category
- Medical Device — Software
- Affected units
- 187
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)
- iConnect Enterprise Archive versions 5.30.0 thru 9.4.3 and V11.0.
Distribution
Distributed nationwide across the United States.
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