—#184285

Product

Olympus Ultrasound Endoscope, Model number: GF-UCT180 - Product Usage: used with an Olympus universal endoscopic ultrasound center or a diagnostic system (ALOKA CO. LTD), video system center, light source, documentation equipment, monitor, EndoTherapy accessories and other ancillary equipment.

FDA product code: IYN — System, Imaging, Pulsed Doppler, Ultrasonic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K093395
Affected lot / code info: All Serial/Lot Numbers

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

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

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy PO Box 610, Center Valley, Pennsylvania 18034-0610

Distribution

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

Timeline

Recall initiated: 2020-10-16
Terminated: 2022-06-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #184285. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.