Recall Z-1865-2012— GE OEC Medical Systems, Inc
Class II · Terminated
Class II FDA medical device recall by GE OEC Medical Systems, Inc, initiated 2006-11-20, terminated 2012-06-25. It names one FDA 510(k) clearance: K993687. Product: OEC Uroview 2800, Model number A349855. Designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures.. Reason: Recalled in November 2006 due to several intermittent potential safety issues including navigation tracking inaccuracy, system Lok-up, incorrect image display, incorrect dose area calculated air kerma in "film mode" and "digital spot mode", and the system does not reboot..
- Recalling firm
- GE OEC Medical Systems, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2006-11-20
- Terminated
- 2012-06-25
- Firm location
- Salt Lake City, UT, United States
510(k) clearances named in this recall
1 on FDA's recordK-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
OEC Uroview 2800, Model number A349855. Designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures.
Reason for recall
Recalled in November 2006 due to several intermittent potential safety issues including navigation tracking inaccuracy, system Lok-up, incorrect image display, incorrect dose area calculated air kerma in "film mode" and "digital spot mode", and the system does not reboot.
Data sourced from openFDA. This site is unofficial and independent of the FDA.