Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Merge Unity is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems
Reported: September 13, 2017 Initiated: August 14, 2017 #Z-3105-2017
Product Description
Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Merge Unity is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems
Reason for Recall
The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation.
Details
- Recalling Firm
- Merge Healthcare, Inc.
- Units Affected
- 98 sites have the potentially affected software
- Distribution
- Nationwide Distribution
- Location
- Hartland, WI
Frequently Asked Questions
What product was recalled? ▼
Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Merge Unity is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems. Recalled by Merge Healthcare, Inc.. Units affected: 98 sites have the potentially affected software.
Why was this product recalled? ▼
The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 13, 2017. Severity: Moderate. Recall number: Z-3105-2017.
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