RecallDepth

GE OEC 9900 Elite ESP To produce mobile fluoroscopic images of human anatomy.

Company
Ge Healthcare
Recall Initiated
August 12, 2009
Posted
January 20, 2010
Terminated
April 23, 2012
Recall Number
Z-0004-2010
Quantity
1411 units total
Firm Location
Salt Lake City, UT

Reason for Recall

A software defect - may result in a false indication and warning on the OEC 9900 Workstation and C-arm display that the X-Ray tube Anode is over-heated. This will also cause the displayed air kerma rate and cumulative air kerma to be inaccurate.

Distribution

Nationwide and Canadian Distribution

Lot / Code Info

All associated serial numbers

Root Cause

Radiation Control for Health and Safety Act

Action Taken

An Important Electronic Product Radiation Warning letter will be sent to customers identifying the issues, interim solution, and permanent solution. Questions or concerns are to be directed to the GEHC OEC service team at 1-800-874-7378.

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