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U.S. Department of Health and Human Services

Class 2 Device Recall GEHC OEC Injection Cable for MedRad Provis V Contrast Injector.

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  Class 2 Device Recall GEHC OEC Injection Cable for MedRad Provis V Contrast Injector. see related information
Date Initiated by Firm October 10, 2008
Date Posted August 23, 2012
Recall Status1 Terminated 3 on January 10, 2013
Recall Number Z-2262-2012
Recall Event ID 62746
510(K)Number K041932  K024012  K022069  K021049  
Product Classification Image-intensified fluoroscopic x-ray system, mobile - Product Code OXO
Product GEHC OEC Injection Cable for MedRad Provis V Contrast Injector.

In certain fluoroscope X-ray modes, the cable provides a signal to the auto-injector to trigger a contrast injection. Part numbers include 00-902260-01 and 00-883654-01.
Code Information Serial Numbers: 82-1138, 82-1586, 82-2089, 82-2117, 82-2182, 82-2214, 82-2226, 82-2262, 82-2264, 82-2308, 82-2312, 82-2314, 82-2321, 82-2328, 82-2380, 82-2391, 82-2438, 82-2483, 82-2512, 82-2516, 82-2535, 82-2722, 82-2796, 82-2821, 82-2846, 82-2848, 82-3052, 82-3055, 82-3129, 82-3144, 82-3170, 82-3171, 82-3201, 82-3256, 82-3267, 82-3314, 82-3350, 82-3361, 82-3377, 82-3467, 82-3468, 82-3659, 82-3709, 82-3722, 82-3859, 82-7016-MH, 82-7022-MH, 82-7037-MH, 82-7055-MH, 82-7062-MH, 82-7080-MH, 82-7086-MH, 82-7105-MH, 82-7114-MH, 82-7124-MH, 82-7131-MH, 82-7133-MH, 82-7137-MH, 82-7141-MH, 82-7154-CMH, 82-7155-MH, 82-7156-MH, 82-7161-MH, 82-7175-MH, 82-7189-MH, 82-7190-MH, 89-1441, 8S-1053, 8S-1436, 8S-2059-C, 8S-7021-CMH, 8S-7023-CMH, 8S-7040-CMH, 8S-7087-CMH, 8S-7164-CMH, DEMO/8S-1355-N, DEMO/E3-7002-MH, E2-0049, E2-0088, E2-0111, E2-0262, E2-7001-MH, E2-7007-MH, E2-7010-MH, E2-7014-MH, E2-7015-MH, E2-7031-MH, E2-7032-MH, E2-7035-MH, E2-7043-MH, E2-7059-MH, E2-7061-MH, E2-7067-MH, E2-7075-MH, E2-7076-MH, E2-7015-MH, & rENTAL/82-7004-MH.
Recalling Firm/
Manufacturer		 GE OEC Medical Systems, Inc
384 Wright Brothers Dr
Salt Lake City UT 84116-2862
For Additional Information Contact Ms. Deena Pease
801-536-4952
Manufacturer Reason
for Recall		 GE initiated a correction to the instructions/use due to the potential for erroneous auto injection of contrast dye.
FDA Determined
Cause 2		 Device Design
Action An Urgent Safety Advisory Notice was sent to consignees on October 10, 2008. The letter identified the affected product and notified customers of the situation, along with instructing them to discontinue use until proper validation and instruction update for cable use was completed. GEHC OEC was to have contacted customers when the solution became available and resolved it at no cost to the customer.
Quantity in Commerce 149 units
Distribution Nationwide distribution.
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) Database 510(K)s with Product Code = OXO and Original Applicant = GE OEC MEDICAL SYSTEMS
510(K)s with Product Code = OXO and Original Applicant = GE OEC MEDICAL SYSTEMS, INC.
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