Z-2566-2018 Class II Terminated
FDA device recall Z-2566-2018 was initiated by Merge Healthcare, Inc. on August 7, 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 18, 2020). Affected quantity: 11 sites have potentially affected software.
Recall Details
- Product Type
- Devices
- Report Date
- August 8, 2018
- Initiation Date
- August 7, 2017
- Termination Date
- May 18, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11 sites have 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 to CA, KY, ME, OH, OR, TN, TX, WA, WV.
Code Information
Software versions 10.0.6 and 10.0.7. Only customers with these 2 versions AND a license for Mammo Tracking are impacted by this recall.