GE OEC UroView 2800 Imaging Systems Field Correction for Component Revision
GE Healthcare is correcting OEC UroView 2800 systems 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 specific safety hazards, fitting the criteria for a voluntary precautionary recall.
Plain-English summary
GE Healthcare has initiated a field correction for certain OEC UroView 2800 imaging systems. The UroView 2800 is designed to provide fluoroscopic and spot-film imaging of patients during diagnostic, surgical, and interventional procedures.
The recall was initiated because prior revisions of components were potentially installed on these systems. This issue may also affect OEC 9800, FlexiView 8800, and OEC MiniView 6800 systems. The affected units were distributed worldwide.
Two specific units are identified by serial numbers P4-0490-R and P6-0705-L. Healthcare facilities should contact GE OEC Medical Systems, Inc. to arrange for the field correction.
The recalled product
- Product
- OEC¿ UroView 2800. The UroView 2800 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
- 2
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)
- Serial No: P4-0490-R and P6-0705-L
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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