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U.S. Department of Health and Human Services

Class 2 Device Recall Ultrasonic Gastrovideoscope/ Endoscopic Ultrasound Endoscopes

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  Class 2 Device Recall Ultrasonic Gastrovideoscope/ Endoscopic Ultrasound Endoscopes see related information
Date Initiated by Firm October 16, 2020
Create Date November 27, 2020
Recall Status1 Terminated 3 on June 07, 2022
Recall Number Z-0503-2021
Recall Event ID 86649
510(K)Number K971660  
Product Classification Gastroscope and accessories, flexible/rigid - Product Code FDS
Product Olympus Ultrasound Endoscope, Model number: GF-UMQ130 - Product Usage: used with an Olympus Endoscopic Ultrasound Center, EVIS Video System Center, light source, documentation equipment, video monitor, Endo-Therapy accessories and other ancillary equipment for endoscopic ultrasound imaging of the gastrointestinal wall, biliary and pancreatic duct, and surrounding organs.
Code Information All Serial/Lot Numbers
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
PO Box 610
Center Valley PA 18034-0610
For Additional Information Contact Laura Storms
484-896-5688
Manufacturer 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.
FDA Determined
Cause 2		 Device Design
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
Quantity in Commerce 31 devices
Distribution 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FDS and Original Applicant = OLYMPUS AMERICA, INC.
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