Recall Z-1034-2022 ยท ITX Transducer, Ultrasonic, Diagnostic
Olympus Corporation of the Americas
Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ultrasound imaging.
| Date | May 5, 2022 (initiated Mar 18, 2022) |
| Status | Open, Classified |
| Reason | 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 | 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 reproces |
| Quantity | 731 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011314 | OLYMPUS GF UC140P-AL5 ULTRASONIC ENDOSCOPE WITH ALOKA SSD-5500 ULTRASOUND SYSTEM Aloka Co., Ltd., May 15, 2001 |