Z-1212-2024 Class II Ongoing
FDA device recall Z-1212-2024 was initiated by Olympus Corporation Of The Americas on Jan 11, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 1.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 6, 2024
- Initiation Date
- Jan 11, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
Product Description
Colonoscope, Model Number PCF-H190TL.
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 Pattern
US Nationwide distribution.
Code Information
Model Number: PCF-H190TL; UDI DI: 04953170420702; Serial Number: 2110150;
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1212-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026