GE Healthcare Recalls OEC 9800 Imaging Systems Due to Power Cable Failures
GE Healthcare is conducting a voluntary field action for OEC 9800 systems because the workstation power cable assembly can cause intermittent power cord failures.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a voluntary precautionary recall for a power cable defect that causes intermittent failures. The source text does not report any injuries, deaths, or specific adverse health consequences, fitting the criteria for a moderate severity score.
Plain-English summary
GE Healthcare Surgery has announced a voluntary field action for the OEC MiniView 6800, OEC 9900 Elite, and OEC 9800 medical imaging systems. The recall is being issued because the workstation power cable assembly can result in intermittent power cord failures.
The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of patients during diagnostic, surgical, and interventional procedures. Clinical applications include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care, and emergency room procedures. The affected units were manufactured between January 1, 2016, and November 1, 2016.
The affected products were distributed worldwide, including in the United States, Canada, Mexico, and Costa Rica. In the U.S., distribution included all 50 states, the District of Columbia, and Puerto Rico. Healthcare facilities should contact GE Healthcare to arrange for the necessary field action to address the power cable assembly issue.
The recalled product
- Product
- OEC 9800. MDL Numbers: D222250, D141598 The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic,
- Manufacturer
- GE OEC Medical Systems, Inc
- Hazard
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 (1)
- Manufactured between 1/1/16 to 11/1/16
Distribution
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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