Recall – PACS viewer synchronization failure

Company: GE Healthcare, LLC
Date of Enforcement Report: 9/29/2021
Class II

PRODUCT

Centricity PACS-IW with Universal Viewer – Product Usage: Is a device that displays medical images (including mammograms) and data from various imaging sources.

Recall Number: Z-2502-2021

REASON

Image acquisition failures and synchronization failure with the Centricity Enterprise Archive.

RECALLING FIRM/MANUFACTURER

GE Healthcare, LLC on 8/6/2021. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

392 (219 US; 173 OUS) all products

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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