GE OEC FlexiView 8800 Imaging System Recalled for Power Cord Failures
GE is recalling OEC FlexiView 8800 systems where specific power cords were replaced in 2016 due to intermittent failures causing loss of imaging functionality.
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 recall is classified as FDA Class II, but the hazard is limited to a loss of functionality (intermittent power failure) with no reported injuries or illnesses, fitting the criteria for a moderate severity recall involving a risk-of-harm product where injury has not been reported.
Plain-English summary
GE OEC Medical Systems, Inc. is recalling one OEC FlexiView 8800 Digital Mobile Imaging System. The recall involves systems where the NEMA 5-15 15 Amp power cords were replaced between January 28, 2016, and November 23, 2016.
The recall is due to a workstation power cable assembly issue that can result in intermittent power cord failures. These failures can cause a loss of imaging functionality. The affected unit was distributed to one consignee in California.
No injuries or illnesses have been reported in connection with this recall. Users should contact GE OEC Medical Systems for further instructions regarding the replacement of the power cable assembly.
The recalled product
- Product
- OEC FlexiView 8800, Digital Mobile Imaging System, GE Medical Systems
- Manufacturer
- GE OEC Medical Systems, Inc
- Affected units
- 1
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 (2)
- 2016 and November 23
- 2016.
Distribution
Distributed in 1 state:
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