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
Enforcement
- Recall Number
- Z-3105-2017
- Event ID
- 77811
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Merge Healthcare, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- September 13, 2017
- Initiation Date
- August 14, 2017
- Classification Date
- September 5, 2017
- Termination Date
- May 8, 2019
- Address
- 900 Walnut Ridge Dr, N/A, Hartland, WI, 53029-8347, United States
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
The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation.
Software versions 10.0, 10.0.1, 10.0.2, 10.0.3, 10.0.4, 10.0.5, 11.0, 11.0.1, 11.0.2, 11.0.3, 11.0.4, 11.1, 11.1.1, 11.1.1.1, 11.1.1 Patch 2, 11.1.1 Patch 3, 11.1.2, 11.1.2 Patch 1, 11.1.2 Patch 2, 11.1.2 Patch 3, and 11.1.2 Patch 4. Only customers with one of the above listed software versions AND a license for Mammo Tracking are impacted by this recall.
Nationwide Distribution
98 sites have the potentially affected software