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.
Recall
- Recall Number
- Z-2262-2012
- Event Number
- 62746
- Firm
- GE OEC Medical Systems, Inc
- FEI Number
- 1720753
- Product Code
- OXO
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- October 10, 2008
- Posted
- August 23, 2012
- Terminated
- January 10, 2013
- Address
- 384 Wright Brothers Dr, Salt Lake City, UT, 84116-2862
Description
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.
GE initiated a correction to the instructions/use due to the potential for erroneous auto injection of contrast dye.
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.
Nationwide distribution.
149 units