GE OEC 9800 C-arm Systems Recalled for Power Supply Defect
GE OEC Medical Systems is recalling 8,214 OEC 9800 C-arm systems worldwide because the vertical lift column power supply is defective and subject to early life failure.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class I, which corresponds to a 'Severe' severity score (4) under the rubric, as Class I recalls represent a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Plain-English summary
GE OEC Medical Systems, Inc. is recalling 8,214 units of the OEC 9800, OEC FluoroTrak 9800 Plus, OEC 9800 Plus, and OEC 9800 MD Motorized C-arm Systems. These are image-intensified fluoroscopic x-ray systems designed for diagnostic, surgical, and interventional procedures. The affected units were distributed worldwide.
The recall is due to a defect in the vertical lift column power supply located in the mainframe C-arm of the device. The source text states that this component is subject to early life failure. The FDA has classified this recall as Class I, noting that the firm has taken action but the recall is being formally classified by the Agency due to administrative issues.
Healthcare facilities and users of these devices should contact GE OEC Medical Systems for further instructions on how to address the defective power supply. No specific consumer actions are detailed in the source text beyond the recall classification and the identification of the defective component.
The recalled product
- Product
- OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional pro
- Manufacturer
- GE OEC Medical Systems, Inc
- Hazard
- Affected units
- 8,214
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)
- 8S-1663
- 8S-2887
- 89-3119
- 89-0098
- 8S-0152-C
- 89-0540
- 82-1252
- 82-1519
- 89-2326
- 89-1204
- 89-3272
- 89-3273
- 8S-0258
- 82-0678
- 82-1884
- 8S-2321
- 82-2042
- 82-3210
- 8S-0533
- 8S-1077
Distribution
Distribution scope not specified by the agency.
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 · power supply failure
See all →- HighGalaxy System bronchoscope power supply defect may injure lung tissue
FDA (Devices) · 2025-01-01
- HighBD FACSLyric Flow Cytometer Power Supply May Fail During Use
FDA (Devices) · 2025-01-01
- HighMedical Device Recall: BD FACSLyric Flow Cytometer Power Supply Failure Risk
FDA (Devices) · 2025-01-01
- HighPhilips Patient Information Center iX UPS devices recalled for potential power failure
FDA (Devices) · 2024-05-01
- ModeratePrucka 3 Amplifier Power Supply May Fail and Cause Device Inoperability
FDA (Devices) · 2023-09-27