GE Healthcare OEC 9900 mobile fluoroscopic x-ray system
FDA Recall Z-0368-2008 · Posted 2008-09-29
Recalling FirmOEC Medical Systems, Inc
Recall StatusTerminated
Product CodeJAA
Date Initiated2007-12-14
Date Terminated2012-04-13
Product Quantity710
Reason for Recall
Possible overexposure: Failure to apply the entrance exposure rate (EER) tube current limit calibration to the automatic exposure rate (AER) control system when the anatomical profile mode is changed from the default selection to another selection. Manual technique modes are not affected.
Firm Action
GE OEC sent a letter to customers December 15, 2007, and scheduled field representative visits for corrective software solution installation.
Root Cause
Software design
Distribution Pattern
Worldwide distribution: USA, Finland, Netherlands, Germany, Switzerland, France, United Kingdom, Australia, Italy, Ireland, Spain, Sweden, Belgium, New Zealand, China, Singapore, Poland, Norway, and India.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.