FDAClass IINovember 11, 2015

The Centricity Universal Viewer Version is a device recall

The Centricity Universal Viewer Version is a device that displays medical images (including mammograms) and data from various imaging sources. Images…

Why was The Centricity Universal Viewer Version is a device recalled?

Inaccurate distance measurements with magnified projection X-ray images.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

2088034-001 DVD UNIVERSAL VIEWER 6.0 - WEB CLIENT

Product
The Centricity Universal Viewer Version is a device that displays medical images (including mammograms) and data from various imaging sources. Images…
Recalling firm
GE Healthcare
Quantity
Centricity Universal Viewer versions 6.0 and higher 5 units
Distribution
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.
Recall date
November 11, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls