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Recall Observatory FDA recall evidence

Device 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.

Z-0226-2016

September 28, 2015

Class II

Product summary

Firm
GE Healthcare
Event
Event 72472
Status
Terminated
Classification
Class II
Quantity
Centricity Universal Viewer versions 6.0 and higher 5 units
Official record key
device-enforcement:Z-0226-2016

Official wording

Reason: Inaccurate distance measurements with magnified projection X-ray images.

Code information: 2088034-001 DVD UNIVERSAL VIEWER 6.0 - WEB CLIENT

Distribution pattern: Worldwide Distribution-US (nationwide) including the states of AZ, CA, CO, DE, FL, GA, IA, IL, IN, LA, MA, MI, MN, MO, NJ, NY, OR, PA, SC, SD, TN, TX, VA, WA, WI and WV, and the countries of Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Ecuador, France, Germany, Ghana, Hong Kong, India, Israel, Italy, Japan, Kenya, Korea, Malta, Malaysia, Namibia, Netherlands, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, Taiwan, United Arab Emirates, United Kingdom and Venezuela.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Inaccurate distance measurements with magnified projection X-ray images.