Merge LIS
This recall has been terminated (originally issued January 23, 2017).
- Company
- Merge Healthcare, Inc.
- Recall Initiated
- January 23, 2017
- Terminated
- May 1, 2021
- Recall Number
- Z-0289-2021
- Quantity
- 47 units
- Firm Location
- Hartland, WI
- Official Source
- View on FDA website ↗
Reason for Recall
A defect in the software resulted in medications that are not associated with the patient (i.e., medications that the patient is not currently taking) appearing on their report.
Distribution
Domestic Distribution Only: Alabama, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kentucky, Louisiana, Maryland, Michigan, Mississippi, Oklahoma, Tennessee, Texas.
Lot / Code Info
Merge LIS versions 4.0.1, 4.1, 4.1.1, 4.1.2, 4.1.3, 4.1.4, 4.1.5, 4.1.5 Patch 1, and 4.1.5 Patch 2
Root Cause
Software design
Action Taken
A defect in the software resulted in medications that are not associated with the patient (i.e., medications that the patient is not currently taking) appearing on their report.