GE OEC Mobile Fluoroscopy Systems Recalled for Power Cable Failures
GE Healthcare is recalling OEC 9900 Elite and other mobile fluoroscopy systems because the workstation power cable assembly can fail intermittently.
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: The recall is a voluntary field action for a power cable defect with no reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
GE Healthcare Surgery has announced a voluntary field action for the OEC MiniView 6800, OEC 9900 Elite, and OEC 9800 mobile fluoroscopy systems. These devices are designed to provide fluoroscopic and spot-film images during diagnostic surgical and interventional procedures. The recall is due to a defect in the workstation power cable assembly, which can result in intermittent power cord failures.
The affected units were manufactured between January 1, 2016, and November 1, 2016. The distribution pattern includes the United States (all states and Puerto Rico) and internationally to Canada, Mexico, and Costa Rica. The OEC 9900 Elite is identified by MDL Numbers D148942 and D155043.
Healthcare facilities should contact GE Healthcare to arrange for the field action. The source text does not specify the exact corrective action steps or the number of affected units.
The recalled product
- Product
- The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional procedure. Examples of 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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