Class II
Medical Device Recall: Colonoscope, Model Number PCF-H190TL.
Olympus Corporation of the Americas · January 11, 2024
Reason for Recall
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.
Distribution
US Nationwide distribution.
States Affected
NATIONWIDE
Quantity Affected
1
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1212-2024
Status: ongoing
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