Recall StatusTerminated
Date Initiated2020-10-16
Date Terminated2022-06-07
Product Quantity2,691
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.
Firm Action
Our records indicate that your facility has purchased one or more of the affected GF-UCT140-AL5 endoscopes/GF-UC140P-AL5 endoscopes/EUS endoscopes. OMSC requests you to take the following actions:
1. Inspect your inventory for the referenced devices and identify any device with the model number specified above. Please check all areas of the hospital to determine if any of these devices remain in inventory. The model number can be found on the device as illustrated in the following picture.
2. Carefully read the content of this Medical Device Correction Action as well as the attached Addendum. This Addendum contains the instructions on how to determine if there is a full blockage of the air/water channel.
3. Ensure all personnel are completely knowledgeable and thoroughly trained on the new inspection steps. The new inspection steps are performed immediately after the clinical procedure and prior to endoscope reprocessing.
4. After November 2020 additional copes of the new Operation Manuals can be obtained by accessing our OlympusConnect site and downloading a copy of the new Manuals. Please visit our OlympusConnect customer website: at https://OlympusConnect.com. New users will need to register. Once registered select [Product Support] on the left navigation bar, then select [Operation Manuals], locate the Model name.
5. Access the Olympus recall portal to indicate that you have received this notification. Go to https://olympusamerica.com/recall. Enter the recall number Recall-0XXX and provide your contact information as indicated in the portal.
6. If you have further distributed this product, identify your customers, forward them this notification, and appropriately document your notification process.
If you require additional information about the new inspection steps, you can obtain additional information as follows:
You can contact our Technical Assistance Center (TAC) at 1-800-848-9024, option 1. The TAC department can assist you in ans
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.