Z-0419-2024 Class II Ongoing
FDA device recall Z-0419-2024 was initiated by Aizu Olympus Co., Ltd. on October 16, 2023 and is designated Class II. Reason for recall: Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decre… The recall status is ongoing. Affected quantity: 24 incorrectly repaired units.
Recall Details
- Product Type
- Devices
- Report Date
- December 6, 2023
- Initiation Date
- October 16, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24 incorrectly repaired units
Product Description
PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE
Reason for Recall
Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.
Distribution Pattern
Domestic distribution to FL, KY, MA, NJ, NY, and PA
Code Information
UDI-DI 04953170305191 Serial Numbers 2302719, 2516751