Z-0289-2021 Class II Terminated
FDA device recall Z-0289-2021 was initiated by Merge Healthcare, Inc. on January 23, 2017 and is designated Class II. 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. The recall status is terminated (terminated May 1, 2021). Affected quantity: 47 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 4, 2020
- Initiation Date
- January 23, 2017
- Termination Date
- May 1, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 47 units
Product Description
Merge LIS
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 Pattern
Domestic Distribution Only: Alabama, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kentucky, Louisiana, Maryland, Michigan, Mississippi, Oklahoma, Tennessee, Texas.
Code Information
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