Recall Z-0973-2017— GE OEC Medical Systems, Inc
Class II · Terminated
Class II FDA medical device recall by GE OEC Medical Systems, Inc, initiated 2016-12-19, terminated 2017-08-22. It names 2 FDA 510(k) clearances: K132027, K111551. Product: OEC 9800. MDL Numbers: D222250, D141598 The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.. Reason: GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elite, and OEC 9800 because the workstation power cable assembly can result in intermittent power cord failures..
- Recalling firm
- GE OEC Medical Systems, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-12-19
- Terminated
- 2017-08-22
- Firm location
- Salt Lake City, UT, United States
510(k) clearances named in this recall
2 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 9800. MDL Numbers: D222250, D141598 The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.
Reason for recall
GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elite, and OEC 9800 because the workstation power cable assembly can result in intermittent power cord failures.
Data sourced from openFDA. This site is unofficial and independent of the FDA.