Recall Z-0195-2015— GE OEC Medical Systems, Inc
Class II · Terminated
Class II FDA medical device recall by GE OEC Medical Systems, Inc, initiated 2014-10-03, terminated 2015-03-23. It names 4 FDA 510(k) clearances: K132027, K111551, K022069 and 1 more. Product: Series OEC 9800. The Series OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient,during diagnostic, surgical and interventional procedures.. Reason: GE Healthcare initiated a field correction because prior revision of components were potentially installed on certain OEC 9800, FlexiView 8800, OEC MiniView 6800 and OEC UroView 2800 systems..
- Recalling firm
- GE OEC Medical Systems, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-10-03
- Terminated
- 2015-03-23
- Firm location
- Salt Lake City, UT, United States
510(k) clearances named in this recall
4 on FDA's record- K132027 — OEC 9800 PLUS
- K111551 — OEC(R) 9800, OEC(R) 9800 PLUS
- 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
Series OEC 9800. The Series OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient,during diagnostic, surgical and interventional procedures.
Reason for recall
GE Healthcare initiated a field correction because prior revision of components were potentially installed on certain OEC 9800, FlexiView 8800, OEC MiniView 6800 and OEC UroView 2800 systems.
Data sourced from openFDA. This site is unofficial and independent of the FDA.