Z-2062-2019 Class II Terminated
FDA device recall Z-2062-2019 was initiated by Merge Healthcare, Inc. on July 11, 2019 and is designated Class II. Reason for recall: Potential for prior thumbnails to not display in reverse chronological order and images may not scroll in reverse chronological order when mammography stacked scrolling is enabled. Merge PACS pro… The recall status is terminated (terminated March 17, 2023). Affected quantity: 179 devices.
Recall Details
- Product Type
- Devices
- Report Date
- July 31, 2019
- Initiation Date
- July 11, 2019
- Termination Date
- March 17, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 179 devices
Product Description
Reason for Recall
Distribution Pattern
Nationwide distribution to Arizona, Arkansas, California, Colorado, Florida, Georgia, Hawaii, Illinois, Iowa, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, South Carolina, Texas, Utah, Virginia, Wisconsin. International distribution to Belgium and Canada.