GE OEC 9800 Medical Imaging Systems Field Correction for Component Revision
GE Healthcare is correcting 311 OEC 9800 imaging systems worldwide because prior component revisions may have been incorrectly installed.
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 2/5 (Moderate).
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 source describes a field correction for potentially incorrectly installed components without reporting any injuries, illnesses, or deaths. This aligns with the rubric for voluntary precautionary recalls or minor issues where harm has not been reported.
Plain-English summary
GE Healthcare has initiated a field correction for 311 units of the Series OEC 9800 medical imaging system. These devices are designed to provide fluoroscopic and spot-film imaging during diagnostic, surgical, and interventional procedures. The recall number is Z-0195-2015.
The field correction is being conducted because prior revisions of components were potentially installed on certain OEC 9800, FlexiView 8800, OEC MiniView 6800, and OEC UroView 2800 systems. The affected units were distributed worldwide.
Healthcare facilities should contact GE OEC Medical Systems, Inc. to verify if their specific serial number is affected and to schedule the necessary field correction.
The recalled product
- Product
- Series OEC 9800. The Series OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient,during diagnostic, surgical and interventional procedures.
- Manufacturer
- GE OEC Medical Systems, Inc
- Hazard
- Affected units
- 311
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)
- Serial No: 82-0013
- 82-0045
- 82-0061
- 82-0071
- 82-0085
- 82-0122
- 82-0133
- 82-0190
- 82-0246
- 82-0357
- 82-0528
- 82-0533
- 82-0597
- 82-0626
- 82-0699
- 82-0702
- 82-0707
- 82-0718
- 82-0805
- 82-0818
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 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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