Class 2 Device Recall GE OEC 9900 Elite GSP fluoroscopic xray system
|Date Initiated by Firm
||August 29, 2008
|Date Posting Updated
||January 05, 2009
||Terminated 3 on April 24, 2012
|Recall Event ID
||Fluoroscopic x-ray system - Product Code JAA
||GE OEC 9900 Elite GSP fluoroscopic x-ray system GE Healthcare, Surgery, Salt Lake City, UT. The system is intended to provide an x-ray display of human anatomy.
ES-0453,, ES-0457,, ES-0466,, ES-0470,, ES-0471,, ES-0473,, ES-0474,, ES-0475,, ES-0477,, ES-0481,, ES-0489,, ES-0491,, ES-0492,, ES-0503
ES-0504,, ES-0505,, ES-0507,, ES-0508,, ES-0516
ES-0517,, ES-0519,, ES-0520,, ES-0530,, ES-0531,, ES-0537
ES-0540,, ES-0542,, ES-0543,, ES-0546,, ES-0548,, ES-7002-MH, and, ES-7029-MH..
| OEC Medical Systems, Inc
384 Wright Brothers Dr
Salt Lake City UT 84116-2862
|For Additional Information Contact
|Under certain conditions, x-ray system may experience operational impairment.
||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.
|Quantity in Commerce
||Nationwide, including AK, KY, NC, VA WA. and WI
|Total Product Life Cycle
TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
||510(K)s with Product Code = JAA and Original Applicant = PT PRODUCTS, LLC