GE OEC Motorized C-Arm Systems Recalled for Defective Power Supply
GE OEC Medical Systems is recalling OEC 9800 series motorized C-arm systems because a defective vertical lift column power supply is subject to early life failure.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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, and the source text does not report any illnesses, injuries, or deaths, placing it in the 'High' severity category for risk-of-harm products where injury has not yet been reported.
Plain-English summary
GE OEC Medical Systems, Inc. is recalling OEC 9800, OEC FluoroTrak 9800 Plus, OEC 9800 Plus, and OEC 9800 MD Motorized C-arm Systems. These devices are designed to provide fluoroscopic and spot-film imaging of patients during diagnostic, surgical, and interventional procedures. The recall covers 11,100 units that were distributed worldwide.
The recall was initiated following an FDA inspection that identified a defect in the vertical lift column power supply within the mainframe C-arm. The inspection determined that this component is subject to early life failure. The agency has now classified this action as a Class II recall, noting that the firm had previously taken action but the classification was delayed due to administrative issues.
The affected units include specific part numbers: 00-884909-01, 00-884777-01, 00-884911-01, 00-885553-01, 00-884913-01, 00-885554-01, 00-885555-01, and 00-886289-01. All serial numbers are included in this recall. Healthcare facilities and users should contact GE OEC Medical Systems for further instructions regarding the defective power supply.
The recalled product
- Product
- OEC 9800, OEC FluoroTrak 9800 Plus, OEC 9800 Plus, OEC 9800 MD Motorized C-arm System designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The OEC 9800 is designed to provide fluoroscopic and…
- Manufacturer
- GE OEC Medical Systems, Inc
- Hazard
- Affected units
- 11,100
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 (8)
- Part numbers: 00-884909-01
- 00-884777-01
- 00-884911-01
- 00-885553-01
- 00-884913-01
- 00-885554-01
- 00-885555-01
- 00-886289-01. All serial numbers.
Distribution
Distribution scope not specified by the agency.
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 · mechanical failure
See all →- SevereCanon Medical Alphenix INFX-8000C/B5 Recalled for Tabletop Shift Risk
FDA (Devices) · 2026-10-14
- ModerateLeMaitre TufTex Over-the-Wire Embolectomy Catheter Recalled for Balloon Failure
FDA (Devices) · 2026-10-14
- HighMirion Captus 4000e Thyroid Uptake System Recalled for Spring Arm Failure
FDA (Devices) · 2026-09-23
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
Similar recalls
- SevereGE OEC 9800 C-arm Systems Recalled for Power Supply Defect
FDA (Devices) · 2012-08-01
- ModerateGE Healthcare Recalls OEC 9800 and 9900 C-Arms for Dose Display Issues
FDA (Devices) · 2020-09-09
- ModerateGE Healthcare Recalls OEC 9800 Imaging Systems Due to Power Cable Failures
FDA (Devices) · 2017-01-18
- ModerateGE OEC Mobile Fluoroscopy Systems Recalled for Power Cable Failures
FDA (Devices) · 2017-01-18
- HighOEC Elite Mobile C-Arm Recalled for Battery Depletion
FDA (Devices) · 2021-08-04
- HighGE OEC Medical Systems Recalls OEC 9800 Plus Digital Imaging Systems
FDA (Devices) · 2012-08-08