Sep

2021

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

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Recall – PACS viewer synchronization failure

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