GE Healthcare Recalls FlexiView 8800 Digital Mobile Imaging Systems
GE Healthcare is recalling five FlexiView 8800 systems because prior component revisions were potentially installed on these units.
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 installed components without reporting specific injuries, illnesses, or FDA Class I classification, fitting the criteria for a voluntary precautionary recall.
Plain-English summary
GE Healthcare has initiated a field correction for five FlexiView 8800 Digital Mobile Imaging Systems. These devices are 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 certain OEC 9800, FlexiView 8800, OEC MiniView 6800, and OEC UroView 2800 systems. The affected units have serial numbers 3120PU3, 4851PU2, 5640PU8, 6052PU5, and FIB0064.
The affected products were distributed worldwide. Healthcare facilities should contact GE Healthcare for further instructions regarding the field correction.
The recalled product
- Product
- FlexiView 8800 Digital Mobile Imaging System. The FlexiView 8800 Digital Mobile Imaging System 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
- 5
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 (5)
- Serial No: 3120PU3
- 4851PU2
- 5640PU8
- 6052PU5
- FIB0064
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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