Merge Healthcare Software Recall for Inaccurate Z-Score Calculations
Merge Healthcare is recalling specific versions of Merge Cardio software due to a calculation error that may produce false negative Z-Scores.
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 risk-of-harm product (medical device software) where the error could lead to false negatives in clinical diagnostics, but no injuries or illnesses have been reported.
Plain-English summary
Merge Healthcare, Inc. is recalling 62 units of Merge Application Server Software and Merge Cardio Workstation Software. The affected software versions are 10.X and 11.X with Knowledge Base versions 3.3, 3.4, 3.5, or 5.0 installed on or before February 21, 2020. The products were distributed nationwide in the United States, including in Illinois, Texas, Oregon, Arizona, Ohio, Tennessee, California, Utah, Missouri, Georgia, New Mexico, Oklahoma, Virginia, Indiana, Connecticut, and Vermont.
The recall is due to an error in the calculation of Michigan Reference Ranges, which can generate an inaccurate Z-Score calculation. This error may reduce the sensitivity of the Z-Score in detecting an abnormality, potentially resulting in a false negative. The software is intended to acquire, store, print, transfer, and archive clinical information, including images, hemodynamic studies, and cardiology signal data.
Healthcare facilities using the affected software should contact Merge Healthcare for instructions on how to resolve the issue. No specific consumer action is required for the general public, as this is a medical device software recall affecting clinical settings.
The recalled product
- Product
- Merge Healthcare Merge Application Server Software Release and Merge Healthcare Merge Cardio Workstation Software Release - Product Usage: VERICIS is a system intended to be used to acquire, store, print, transfer, and archive clinical information from Camtronics and other vendor
- Manufacturer
- Merge Healthcare, Inc.
- Affected units
- 62
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 (5)
- Merge Cardio versions 10.X and 11.X with Knowledge Base versions 3.3
- 3.4
- 3.5 or 5.0 installed on or before February 21
- 2020. Version 10.0 Pre-UDI Application server PN 88-00528-00
- Workstation PN:30-01654-00
Distribution
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