Z-2591-2017 Class II Terminated
FDA device recall Z-2591-2017 was initiated by Merge Healthcare, Inc. on May 8, 2017 and is designated Class II. Reason for recall: When cut lines are shown on an image, the lines may go from being vertical and then shift to horizontal causing confusion to the physician. This may cause a misdiagnosis. The recall status is terminated (terminated August 8, 2019). Affected quantity: 47 sites have the potentially affected versions.
Recall Details
- Product Type
- Devices
- Report Date
- June 21, 2017
- Initiation Date
- May 8, 2017
- Termination Date
- August 8, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 47 sites have the potentially affected versions
Product Description
Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication, and storage of studies produced by digital modalities, including digital mammography
Reason for Recall
When cut lines are shown on an image, the lines may go from being vertical and then shift to horizontal causing confusion to the physician. This may cause a misdiagnosis.
Distribution Pattern
Nationwide Distribution
Code Information
Versions 7.0.2.1, 7.0.2.2, 7.0.2.3, 7.0.2.3 P1, and 7.0.2.3 P2