Date Initiated by Firm | October 16, 2020 |
Create Date | November 27, 2020 |
Recall Status1 |
Terminated 3 on June 07, 2022 |
Recall Number | Z-0505-2021 |
Recall Event ID |
86649 |
510(K)Number | K010591 |
Product Classification |
Endoscopic ultrasound system, gastroenterology-urology - Product Code ODG
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Product | Olympus Ultrasound Endoscope, Model number: GF-UC160P-OL5 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human body. |
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
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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 | 46 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 |
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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.
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510(K) Database | 510(K)s with Product Code = ODG
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