GE Healthcare Recalls DeltaVision OMX SR Imaging Systems Due to Interlock Defect
GE Healthcare Biosciences is recalling 39 DeltaVision OMX SR Imaging Systems because the safety interlocks are not wired to be single-fault tolerant.
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. The hazard is a safety interlock defect in laboratory equipment, which is a significant risk but does not meet the criteria for Severe (Class I or structural vehicle defect) or High (allergen/pathogen).
Plain-English summary
GE Healthcare Biosciences is recalling 39 units of the DeltaVision OMX SR Imaging System, Model Number 29115476. This laboratory equipment is used for super resolution imaging of fluorescently-labeled biological samples. The affected units have serial numbers ranging from OM20072 to OM40122.
The recall is due to a non-conformance in the safety interlock system. The interlocks are not wired in a redundant fashion, which means the system is not single-fault tolerant. This defect could potentially compromise the safety mechanisms of the equipment.
The affected units were distributed worldwide and nationwide in the United States. Users of this equipment should contact GE Healthcare Biosciences for instructions on how to address the defect.
The recalled product
- Product
- DeltaVision OMX SR Imaging System Model Number: 29115476 The DeltaVision OMX SR Imaging System is a piece of laboratory equipment for super resolution imaging offluorescently-la beling biological samples. Techniques such as 3D Structured Illumination, Total Internal…
- Manufacturer
- GE Healthcare Biosciences
- Hazard
- Affected units
- 39
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)
- System Serial number OM20072 - OM40122
Distribution
Distributed nationwide across the United States.
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