—#192924

Product

Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ultrasound imaging.

FDA product code: ITX — Transducer, Ultrasonic, Diagnostic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K011314
Affected lot / code info: All serial numbers. GTIN: 04953170356322

Why it was recalled

GF-UC140P-AL5 is no longer a compatible endoscope for reprocessing in the OER-Pro and presents an infection control risk to patients

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy, Center Valley, Pennsylvania 18034-8229

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2022-03-18
Posted by FDA: 2022-05-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #192924. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.