Recall Z-2262-2012— GE OEC Medical Systems, Inc
Class II · Terminated
Class II FDA medical device recall by GE OEC Medical Systems, Inc, initiated 2008-10-10, terminated 2013-01-10. It names 4 FDA 510(k) clearances: K041932, K024012, K022069 and 1 more. 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.. Reason: GE initiated a correction to the instructions/use due to the potential for erroneous auto injection of contrast dye..
- Recalling firm
- GE OEC Medical Systems, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2008-10-10
- Terminated
- 2013-01-10
- Firm location
- Salt Lake City, UT, United States
510(k) clearances named in this recall
4 on FDA's record- K041932 — OEC OLYMPUS FLUOROSCOPIC IMAGING SYSTEM
- K024012 — OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM
- K022069 — OEC FLUOROTRAK 9800 PLUS
- K021049 — OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product 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.
Reason for recall
GE initiated a correction to the instructions/use due to the potential for erroneous auto injection of contrast dye.
Data sourced from openFDA. This site is unofficial and independent of the FDA.