Class 2 Device Recall Olympus Ultrasonic Gastrovideoscope

• Date Initiated by Firm: March 18, 2022
• Date Posted: May 05, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1034-2022
• Recall Event ID: 89921
• 510(K)Number: K011314
• Product Classification: Transducer, ultrasonic, diagnostic - Product Code ITX
• Product: Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ultrasound imaging.
• Code Information: All serial numbers. GTIN: 04953170356322
• Recalling Firm/ Manufacturer: Olympus Corporation of the Americas; 3500 Corporate Pkwy; Center Valley PA 18034-8229
• For Additional Information Contact: SAME; 484-896-5000
• Manufacturer Reason for Recall: GF-UC140P-AL5 is no longer a compatible endoscope for reprocessing in the OER-Pro and presents an infection control risk to patients
• FDA Determined Cause: Device Design
• Action: Olympus issued URGENT: MEDICAL DEVICE CORRECTIVE ACTION on 3/18/22. Letter states reason for recall, health risk and action to take: 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. If you are using the OER-Pro for high level disinfection of the GF-UC140P-AL5, please transition to an OER-Elite or another AER validated for GF-UC140P-AL5 reprocessing as soon as possible. 3. When manually cleaning the GF-UC140P-AL5 carefully follow the instructions in the IFU, vigilantly cleaning all channels and the forceps elevator. Ensure that you are inspecting the GFUC140P-AL5 prior to each use and after each use according to the instructions. 4. Ensure all personnel understand that the GF-UC140P-AL5 is no longer a compatible endoscope for reprocessing in the OER-Pro and further that such personal are completely knowledgeable and thoroughly trained on the Instructions for Use applicable to the GF-UC140P-AL5 device 5. Access the Olympus recall portal to indicate that you have received this notification. Go to https://olympusamerica.com/recall. Enter the recall number 0406 and provide your contact information as indicated in the portal. If you require additional information about the GF-UC140P-AL5 reprocessing, you can obtain additional information as follows: You can contact our Technical Assistance Center (TAC) at 1-800-848-9024, option 1 and the TAC department can assist you in answering questions. OMSC requests you to report any patient injuries, including infections or persistent microbial colonization associated with any OMSC endoscope. Call our Technical Assistance Center (TAC) at 1- 800-848-9024, option 1 to report complaints.
• Quantity in Commerce: 731 units
• Distribution: Nationwide
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = ITX and Original Applicant = ALOKA CO., LTD.