Recall – PACS measurements may be incorrect

Company: Merge Healthcare, Inc.
Date of Enforcement Report: 9/16/2020
Class II

PRODUCT

Merge PACS

Recall Number: Z-2944-2020

REASON

Measurements done on the Merge PACS generated MPR s may have incorrect measurements.

RECALLING FIRM/MANUFACTURER

Merge Healthcare, Inc. on 8/6/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

125 total units

DISTRIBUTION

U.S. Nationwide and International

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN), Canada, and Italy.