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: June 21, 2017 Initiated: May 8, 2017 #Z-2591-2017
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
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.
Details
- Recalling Firm
- Merge Healthcare, Inc.
- Units Affected
- 47 sites have the potentially affected versions
- Distribution
- Nationwide 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: 47 sites have the potentially affected versions.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 21, 2017. Severity: Moderate. Recall number: Z-2591-2017.
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