Olympus HF Cable WA00014A Recalled for Software Malfunction
Olympus Corporation of the Americas is recalling 494 HF Cable WA00014A units due to a software malfunction that may cause incorrect error codes to be generated or displayed.
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, and the source text does not report any injuries, illnesses, or deaths. The hazard is a software malfunction affecting error code display, which is a functional defect without reported physical harm, fitting the Moderate criteria for a precautionary recall of a device with a non-critical defect.
Plain-English summary
Olympus Corporation of the Americas is recalling 494 units of the HF Cable WA00014A, an endoscopic electrosurgical unit accessory. The recall is being conducted because of a software malfunction that results in the incorrect generation or display of error codes.
The affected units were distributed nationwide. The specific lot numbers involved are 158W, 159W, 15XW, 15YW, 15ZW, 161W, 162W, 163W, 164W, 165W, 166W, and 167W.
Healthcare facilities and users should stop using the affected cables and contact Olympus Corporation of the Americas for instructions on how to proceed with the recall.
The recalled product
- Product
- HF Cable WA00014A, Endoscopic electrosurgical unit and accessories
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 494
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 (12)
- Model Number: WA00014A Lot Numbers: 158W
- 159W
- 15XW
- 15YW
- 15ZW
- 161W
- 162W
- 163W
- 164W
- 165W
- 166W
- 167W
Distribution
Distributed nationwide across the United States.
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