Z-0499-2021 Class II Terminated
FDA device recall Z-0499-2021 was initiated by Olympus Corporation of the Americas on October 16, 2020 and is designated Class II. Reason for recall: A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections. The recall status is terminated (terminated June 7, 2022). Affected quantity: 564.
Recall Details
- Product Type
- Devices
- Report Date
- December 9, 2020
- Initiation Date
- October 16, 2020
- Termination Date
- June 7, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 564
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US Nationwide distribution. Model Name ------------ Quantity distributed in U.S. GF-UC140P-AL5 ------------- 1,297 devices GF-UCT150-AL5 ------------- 564 devices GF-UCT180 -------------------- 3,145 devices GF-UM20 ----------------------- 31 devices GF-UM130 --------------------- 27 devices GF-UMQ130 ------------------- 373 devices GF-UM160 --------------------- 299 devices GF-UC160P-OL5 ------------- 46 devices GF-UCT160-OL5 ------------- 49 devices GF-UE160-AL5 -------------- 2,691 devices