FDAFDA · Food and drugs·Recall number Z-1274-2022
Colonovideoscope Model CF-H180AL
Published June 29, 2022 · Recall initiated: April 22, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
A (Camera unit) CCD intended for a different model of colonoscope may have been installed in the CF-H180AL, viewing angle would be narrower than a normal CF-H180AL and the use of EndoTherapy devices may stick out (approximately 1.4 mm) further than normal protrusion,could lead to patient injury; specifically, mucosal damage that could result in hemorrhage or bleeding
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Olympus Corporation of the Americas
- Distributor
- US Nationwide distribution in the state of KY.
- Lot
- UDI-DI: 04953170339615 Serial number: 2501131
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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