Merge PACS software. Product Usage: 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.
Reported: November 23, 2016 Initiated: March 28, 2016 #Z-0599-2017
Product Description
Merge PACS software. Product Usage: 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
The software did not show unviewed images when the last view was skipped. The physician may potentially misdiagnose when not all images are available for viewing.
Details
- Recalling Firm
- Merge Healthcare, Inc.
- Units Affected
- 534 sites potentially have the affected versions
- Distribution
- Worldwide Distribution - US Nationwide including Canada.
- Location
- Hartland, WI
Frequently Asked Questions
What product was recalled? ▼
Merge PACS software. Product Usage: 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.. Recalled by Merge Healthcare, Inc.. Units affected: 534 sites potentially have the affected versions.
Why was this product recalled? ▼
The software did not show unviewed images when the last view was skipped. The physician may potentially misdiagnose when not all images are available for viewing.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 23, 2016. Severity: Moderate. Recall number: Z-0599-2017.
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