Z-3105-2017 Class II Terminated
FDA device recall Z-3105-2017 was initiated by Merge Healthcare, Inc. on August 14, 2017 and is designated Class II. Reason for recall: The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation. The recall status is terminated (terminated May 8, 2019). Affected quantity: 98 sites have the potentially affected software.
Recall Details
- Product Type
- Devices
- Report Date
- September 13, 2017
- Initiation Date
- August 14, 2017
- Termination Date
- May 8, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 98 sites have the potentially affected software
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.
Distribution Pattern
Nationwide Distribution
Code Information
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.