OES 4000 Hysteroscope recall
OES 4000 Hysteroscope, Model/Catalog Number: A4674A
Why was OES 4000 Hysteroscope recalled?
The required leakage test was not performed following of a re-work for a non-conformity. This could potentially result in liquid ingress into the eyepiece and cause a foggy image.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model/Catalog Number: A4674A, UDI-DI: 04042761006361, Serial Number: 805904;
- Product
- OES 4000 Hysteroscope, Model/Catalog Number: A4674A
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 1 unit
- Distribution
- US Nationwide distribution in the state of NY.
- Recall date
- June 12, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)