RecallDepth

GE Healthcare, Mobile Fluoroscopy X-Ray System, OEC Model 7600, GE Healthcare, Surgery, Salt Lake City, Utah.

Company
Ge Oec Medical Systems, Inc
Recall Initiated
September 28, 2007
Posted
March 15, 2008
Terminated
November 1, 2011
Recall Number
Z-0716-2008
Quantity
157 units (Domestic), 142 units (Foreign)
Firm Location
Salt Lake City, UT

Reason for Recall

Unnecessary operator exposure; X-ray machine may allow unwanted x-ray exposure to the operator.

Distribution

Worldwide- USA including states of CO, DE, FL, NJ, MO, NY, PA, and TX (with VA and Military facilities) and countries of Australia, Austria, Belgium, Brazil, Chile, China, The Czech Republic, Denmark, France, Germany, Hungary, Israel, Italy, Norway, Spain, Sweden, Switzerland, Thailand, and The UK.

Lot / Code Info

All Serial Numbers

Root Cause

Other

Action Taken

On or about 9/6/2007, by Customer Notification Letter, users were notified that all affected units will be corrected by GE personnel with the addition of an additional shield.

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