21
Jun
2017

Merge: Merge PACS software Cl II

0

Company: Merge Healthcare, Inc.
Date of Enforcement Report 6/21/2017
Class lI:

PRODUCT

Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication, and storage of studies produced by digital modalities, including digital mammography
Recall Number Z-2591-2017

REASON
Merge PACS did not show unviewed images when the last view was skipped. There is a potential risk to health of a physician misdiagnosis because not all images are available for viewing.

RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc., Hartland, WI on 5/8/2017. Voluntary: Firm Initiated recall is ongling.

VOLUME OF PRODUCT IN COMMERCE
47 sites potentially have the affected versions

DISTRIBUTION
Nationwide

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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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