Company: GE Healthcare.
Date of Enforcement Report 11/11/2015
Class lI:
PRODUCT
The Centricity Universal Viewer Version is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants.
Recall Number Z-0226-2016
REASON
Inaccurate distance measurements with magnified projection X-ray images.
RECALLING FIRM/MANUFACTURER
GE Healthcare, Barrington, IL on 9/28/2015. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
Centricity Universal Viewer versions 6.0 and higher 5 units
DISTRIBUTION
Nationwide and Internationally
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