Company: GE Healthcare It.
Date of Enforcement Report 8/11//2010
Class ll:
PRODUCT
1) GE Centricity PACS-IW software. Device that receives stores and communicates medical images and data from various imaging sources. Recall # Z-1402-201;
2)GE Centricity Web Diagnostic (WebDX) software; Device that receives stores and communicates medical images and data from various imaging sources. Recall # Z-1403-2010
REASON
There is a potential safety issue associated with the use of GE Centricity PACS-IW and PACS Web Diagnostic software when dragging-and-dropping images from the Navigator causing flipping of the images that may impact patient safety.
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare It, Barrington, IL, by letter dated February 11, 2010.
Manufacturer: Dynamic Imaging, LLC, Allendale, NJ. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
42 units
DISTRIBUTION
CA, IL, IN, MN, NV, NY, WI, Austria, Canada, Finland, France, Germany, Ireland, Lebanon, Japan, Philippines, Saudi Arabia, Singapore, Switzerland, Turkey, United Arab Emirates and the United Kingdom
