Colonovideoscope Model CF-H180AL
Reported: June 29, 2022 Initiated: April 22, 2022 #Z-1274-2022
Product Description
Colonovideoscope Model CF-H180AL
Reason for Recall
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
Details
- Recalling Firm
- Olympus Corporation of the Americas
- Units Affected
- 1 unit
- Distribution
- US Nationwide distribution in the state of KY.
- Location
- Center Valley, PA
Frequently Asked Questions
What product was recalled? ▼
Colonovideoscope Model CF-H180AL. Recalled by Olympus Corporation of the Americas. Units affected: 1 unit.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 29, 2022. Severity: Moderate. Recall number: Z-1274-2022.
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