11

Aug

2010

Cl ll GE Centricity software

0

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

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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