FDAFDA · Food and drugs·Recall number Z-2029-2024
OES 4000 Hysteroscope, Model/Catalog Number: A4674A
Published June 12, 2024 · Recall initiated: April 18, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Olympus Corporation of the Americas
- Distributor
- US Nationwide distribution in the state of NY.
- Lot
- Model/Catalog Number: A4674A, UDI-DI: 04042761006361, Serial Number: 805904;
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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