FDA Enforcement
Class II
Ongoing
Colonoscope, Model Number PCF-H180AL.
Recall: Z-1209-2024
·
Reported March 6, 2024
Enforcement
- Recall Number
- Z-1209-2024
- Event ID
- 93832
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Olympus Corporation of the Americas
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 6, 2024
- Initiation Date
- January 11, 2024
- Classification Date
- February 29, 2024
- Address
- 3500 Corporate Pkwy, Center Valley, PA, 18034-8229, United States
Description
Colonoscope, Model Number PCF-H180AL.
Reason
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.
Code Info
Model Number: PCF-H180AL; UDI DI: 04953170339899; Serial Number: 2005061, 2007000, 2108388, 2108779, 2109211, 2109849, 2200674, 2201253, 2301680, 2800321, 2801450, 2801763, 2802289, 2903612, 2903746, 2903896, 2904201, 2904811;
Distribution
US Nationwide distribution.
Quantity
18