Hysteroscope recalled due to missed required leakage test
Olympus OES 4000 Hysteroscope Model A4674A is being recalled because a required leakage test was not performed after device repairs. Liquid could enter the eyepiece, causing a foggy image during use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall with no reported injuries or illnesses. However, it is a risk-of-harm product because the failed quality control test means a surgical instrument may not function properly, creating potential for harm even without currently reported incidents.
Plain-English summary
The OES 4000 Hysteroscope, Model A4674A, manufactured by Olympus Corporation of the Americas, is being recalled. Following rework to address a non-conformity, the required leakage test was not performed to verify the repair.
Without completing the required leakage test, the device has not been verified to prevent liquid ingress. Liquid could enter the eyepiece and cause a foggy image.
Anyone in possession of this device should contact Olympus Corporation of the Americas for recall instructions and guidance on device replacement or repair.
The recalled product
- Product
- OES 4000 Hysteroscope, Model/Catalog Number: A4674A
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- manufacturing-defect
- liquid-ingress
- image-degradation
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 (3)
- Model/Catalog Number: A4674A
- UDI-DI: 04042761006361
- Serial Number: 805904
Distribution
Distributed nationwide across the United States.
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