GE OEC 9900 Elite ESP fluoroscopic x-ray system. GE Healthcare, Surgery, Salt Lake City, UT. The system is intended to provide an x-ray display of human anatomy.
FDA Recall Z-0341-2009 · Posted 2009-01-05
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Recalling FirmOEC Medical Systems, Inc
Recall StatusTerminated
Product CodeJAA
Date Initiated2008-08-29
Date Terminated2012-04-24
Product Quantity606 units
Reason for Recall
Under certain conditions, x-ray system may experience operational impairment.
Firm Action
Consignees were notified by letter on 08/29/2008. Interim solutions were provided for proper start-up procedures and for avoidance of mechanical impact to the C-arm. A start Up caution label was included with the notification. Further information available at 800-874-7378.
Root Cause
Device Design
Distribution Pattern
Nationwide, including AK, KY, NC, VA WA. and WI
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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