GE OEC Medical Systems Recalls OEC 9800 Plus Digital Imaging Systems
GE OEC Medical Systems is recalling OEC 9800 Plus Digital imaging systems due to a hard disk drive issue. The recall covers 82 units distributed worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a reasonable probability of temporary or medically reversible adverse health consequences. The source does not report specific injuries or deaths, placing it in the High severity category per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
GE OEC Medical Systems, Inc. is recalling OEC 9800 Plus Digital imaging systems (MDL number A349855) due to an issue with the installed hard disk drives. The affected devices are designed to provide fluoroscopic and spot-film imaging during diagnostic, surgical, and interventional procedures.
The recall covers 82 units distributed worldwide, including the United States, Canada, France, Japan, and China. The devices were manufactured between October 15, 2004, and an unspecified date. The firm discovered the issue with the hard disk drives on several OEC device models, including the UroView 2800, 9800 Plus Digital, MiniView 6800, and FlexiView 8800 Mobile C-Arm.
This recall is being classified by the FDA due to administrative issues, although the firm has already taken action. The agency has classified this as a Class II recall. Users should contact GE OEC Medical Systems for further instructions regarding the affected devices.
The recalled product
- 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,
- Manufacturer
- GE OEC Medical Systems, Inc
- Category
- Medical Device — Imaging Systems
- Hazard
- Affected units
- 82
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by GE OEC Medical Systems, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · GE OEC Medical Systems, Inc
See all →- HighOEC 9900 Mobile Fluoroscopic X-Ray System Recall for Sealing Defect
FDA (Devices) · 2024-12-25
- HighGE OEC 9800 X-Ray System Recalled for Insufficient Tube Sealing
FDA (Devices) · 2024-12-25
- HighOEC 3D Mobile Fluoroscopic X-Ray System Tube Sealing Defect Recall
FDA (Devices) · 2024-12-25
- HighFluoroscopic X-Ray System Recalled for Insufficient X-Ray Tube Sealing
FDA (Devices) · 2024-12-25
- HighOEC Flexiview 8800 Image Intensifier Risks Detachment During Movement
FDA (Devices) · 2023-08-09
Same hazard · hardware defect
See all →- SevereAutomated Impella Controllers await four pending hardware safety updates
FDA (Devices) · 2026-06-03
- SevereIntra-Aortic Balloon Pumps recalled for unexpected gas loss and gain alarms
FDA (Devices) · 2023-09-06
- SevereCardiosave Rescue IABP Alarms May Trigger Unexpectedly During Therapy
FDA (Devices) · 2023-09-06
- ModerateX-ray imaging system hardware defect may prevent operation
FDA (Devices) · 2022-09-07
- HighHitachi L43K intraoperative probe recall: screw cover may detach during sterilization
FDA (Devices) · 2021-08-25