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.
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, 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 spot-film
- 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.
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