Recall Z-2262-2012 ยท OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
GE OEC Medical Systems, Inc
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.
| Date | Aug 23, 2012 (initiated Oct 10, 2008) |
| Status | Terminated |
| Reason | GE initiated a correction to the instructions/use due to the potential for erroneous auto injection of contrast dye. |
| Root cause | 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 | 149 units |
| Distribution | Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021049 | OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM Ge Oec Medical Systems, Apr 17, 2002 |
| K022069 | OEC FLUOROTRAK 9800 PLUS Ge Oec Medical Systems, Sep 17, 2002 |
| K024012 | OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM Ge Oec Medical Systems, Mar 20, 2003 |
| K041932 | OEC OLYMPUS FLUOROSCOPIC IMAGING SYSTEM Ge Oec Medical Systems, Inc., Aug 18, 2004 |