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.
Reported: December 14, 2016 Initiated: March 28, 2016 #Z-0726-2017
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
Cut lines on the image may present horizontally rather than vertically.
Details
- Recalling Firm
- Merge Healthcare, Inc.
- Units Affected
- 537 sites potentially have the affected versions
- Distribution
- Worldwide Distribution - US (nationwide) Canada and foreign distribution
- Location
- Hartland, WI
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Merge Healthcare, Inc.. Units affected: 537 sites potentially have the affected versions.
Why was this product recalled? ▼
Cut lines on the image may present horizontally rather than vertically.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 14, 2016. Severity: Moderate. Recall number: Z-0726-2017.
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