FDAFDA · Food and drugs·Recall number Z-1212-2024
Colonoscope, Model Number PCF-H190TL.
Published March 6, 2024 · Recall initiated: January 11, 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
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Olympus Corporation of the Americas
- Distributor
- US Nationwide distribution.
- Lot
- Model Number: PCF-H190TL; UDI DI: 04953170420702; Serial Number: 2110150;
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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