GE OEC Medical Systems, Inc OEC 9800 Plus Digital; MDL number A349855. Product Usage: Is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion. 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
OEC 9800 Plus Digital; MDL number A349855. Product Usage: Is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.
Brand
GE OEC Medical Systems, Inc
Lot Codes / Batch Numbers
62-0212, 69-0054, 82-0023-RC, 82-0034, 82-0072, 82-0274, 82-0587, 8S-0668, 82-1710, 82-1803, 82-2147, 82-2620, 82-2754, 82-2815, 82-3014, 82-3234, 82-7010-MH, 86-0254, 86-0354, 86-1078, 89-0505, 89-0509, 89-0595, 89-0605, 89-0987, 89-1048, 89-1776, 89-1837, 89-2132, 89-2303, 89-2335, 89-2348, 89-2350, 89-2610, 89-2645, 8S-0066, 8S-0079, 8S-0341, 8S-0562, 8S-0615-C, 8S-0847, 8S-0849-C, 8S-1312, 8S-1971, 8S-2015-N, 8S-2116, 8S-2117, 8S-2199, 8S-2204, 8S-2320, 8S-2411, P4-0097-R, P4-0101-R, P4-0325-R, P4-0346-L, P4-0477-L, P6-0432-R, W2-0012, W2-0580-R, W2-0591-R, 82-0030
Products Sold
62-0212 , 69-0054 , 82-0023-RC , 82-0034 , 82-0072 , 82-0274 , 82-0587, 8S-0668 , 82-1710 , 82-1803 , 82-2147 , 82-2620 , 82-2754 , 82-2815 , 82-3014 , 82-3234 , 82-7010-MH , 86-0254 , 86-0354 , 86-1078 , 89-0505 , 89-0509 , 89-0595 , 89-0605 , 89-0987 , 89-1048 , 89-1776 , 89-1837 , 89-2132 , 89-2303 , 89-2335 , 89-2348 , 89-2350 , 89-2610 , 89-2645 , 8S-0066 , 8S-0079 , 8S-0341 , 8S-0562 , 8S-0615-C , 8S-0847 , 8S-0849-C , 8S-1312 , 8S-1971 , 8S-2015-N , 8S-2116 , 8S-2117 , 8S-2199 , 8S-2204 , 8S-2320 , 8S-2411 , P4-0097-R , P4-0101-R , P4-0325-R , P4-0346-L , P4-0477-L , P6-0432-R , W2-0012 , W2-0580-R , W2-0591-R , 82-0030
GE OEC Medical Systems, Inc is recalling OEC 9800 Plus Digital; MDL number A349855. Product Usage: Is designed to provide fluoroscopic an due to Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by th. 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
Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE OEC had discovered an issue with the hard disk drives that were installed on OEC device models: UroView 2800; 9800 Plus Digital; MiniView 6800; and FlexiView 8800 Mobile C-Arm. The devices were manufactured between October 15, 2004 and
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 11, 2026