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Terminated

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

FDA Recall Z-3105-2017 · Posted 2017-08-18

Recalling FirmMerge Healthcare, Inc.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2017-08-14
Date Terminated2019-05-08
Product Quantity98 sites have the potentially affected software

Reason for Recall

The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation.

Firm Action

MERGE sent a Medical Device Recall letter dated August 11, 2017, to all affected customers. Customers were advised to discontinue using the affected product and to reply using the enclosed form. Customers with questions were instructed to send an email to [email protected]. For questions regarding this recall call 262-912-3514.

Root Cause

Process design

Distribution Pattern

Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041935DR SYSTEMS PACS, RELEASE 6.1Dr Systems, Inc. · 2004-08-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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