GE OEC Medical Systems, Inc FlexiView 8800 Digital Mobile Imaging System. The FlexiView 8800 Digital Mobile Imaging System is designed to provide fluoroscopic and spot film, imaging of the patient during diagnostic, surgical and interventional procedures. Recall
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
FlexiView 8800 Digital Mobile Imaging System. The FlexiView 8800 Digital Mobile Imaging System is designed to provide fluoroscopic and spot film, imaging of the patient during diagnostic, surgical and interventional procedures.
Brand
GE OEC Medical Systems, Inc
Lot Codes / Batch Numbers
Serial No: 3120PU3, 4851PU2, 5640PU8, 6052PU5, FIB0064
Products Sold
Serial No: 3120PU3, 4851PU2, 5640PU8, 6052PU5, FIB0064
GE OEC Medical Systems, Inc is recalling FlexiView 8800 Digital Mobile Imaging System. The FlexiView 8800 Digital Mobile Imaging System is due to GE Healthcare initiated a field correction because prior revision of components were potentially installed on certain OEC 9800, FlexiView 8800, OEC Mi. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026