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U.S. Department of Health and Human Services

Enforcement Report - Week of August 29, 2012

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Event Detail

Event ID 62746
Product Type Devices
Status Ongoing
Recalling Firm GE OEC Medical Systems, Inc
City Salt Lake City
State UT
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2008-10-10
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Nationwide distribution.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. 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. Class II GE initiated a correction to the instructions/use due to the potential for erroneous auto injection of contrast dye. 149 units Z-2262-2012
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