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

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

Corporate Office

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