Z-2590-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 21, 2017
- Initiation Date
- May 8, 2017
- Termination Date
- August 5, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 47 sites potentially have the affected versions
Product Description
Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
Reason for Recall
Merge PACS did not show unviewed images when the last view was skipped. There is a potential risk to health of a physician misdiagnosis because not all images are available for viewing.
Distribution Pattern
USA (nationwide) Distribution .There was no foreign/government/military 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