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.
- Company
- Ge Oec Medical Systems, Inc
- Recall Initiated
- October 10, 2008
- Posted
- August 23, 2012
- Terminated
- January 10, 2013
- Recall Number
- Z-2262-2012
- Quantity
- 149 units
- Firm Location
- Salt Lake City, UT
Reason for Recall
GE initiated a correction to the instructions/use due to the potential for erroneous auto injection of contrast dye.
Distribution
Nationwide distribution.
Lot / Code Info
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.
Root Cause
Device Design
Action Taken
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.