Cl Il GE Centricity PACS-IW & WebDX software

Company: Ge Healthcare Itc
Date of Enforcement Report 4/21//2010
Class:ll

PRODUCT
1) GE Centricity PACS-IW software; The intended use: The Centricity PACS-IW is used to receive medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Recall # Z-1394-2010;

2) GE Centricity Web Diagnostic 1.0 (WebDX) software; The Intended use: The Centricity PACS-IW is used to receive medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Recall # Z-1395-2010

REASON
There is a potential safety issue associated with the use of GE Centricity PACS-IW and PACS Web Diagnostic software related to use of built-in reconstruction functions which may result in incorrect anatomic orientation markers.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Ge Healthcare It, Barrington, IL, by letters dated February 18, 2010.
Manufacturer: Dynamic Imaging, LLC, Allendale, NJ. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
670 units

DISTRIBUTION
Nationwide and Internationally

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