OEC 9900 Elite Image-intensified fluoroscopic x-ray system (includes OEC 9900 Elite Fluoroscopy System and 9900 EliteMD Motorized C-arm System), GE Healthcare, Surgery, Salt Lake City, UT.
FDA Recall Z-1706-2008 · Posted 2008-09-01
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Recalling FirmOEC Medical Systems, Inc
Recall StatusTerminated
Product CodeJAA
Date Initiated2008-04-15
Date Terminated2011-12-21
Product Quantity25 units
Reason for Recall
Use of existing four-pedal footswitch on a different machine may cause various operational errors.
Firm Action
Consignees were notified by letter on 03/21/2007 and advised that GE would be replacing the 4-pedal switches at some time in the future. Replacement began on 04/15/2008. Contact GE Healthcare at 1-800-874-7378 for assistance.
Root Cause
Device Design
Distribution Pattern
Nationwide, including one VA facility in FL. No military or foreign distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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