Recall Z-1275-2022 ยท FDS Gastroscope And Accessories, Flexible/Rigid
Olympus Corporation of the Americas
EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model: GIF-HQ190
| Date | Apr 22, 2022 |
| Status | Open, Classified |
| Reason | Part (A-rubber) intended for a different model of gastrointestinal videoscope may have been used when replacing part on GIF-HQ190 during the last repair at Olympus. An Incorrect A-rubber fits tighter on the GIF-HQ190 which would not meet the intended design specifications |
| Root cause | Nonconforming Material/Component |
| Action | Olympus issued Urgent Medical Device Correction letter via email on 4/22/22. Letter states reason for recall, health risk and action to take: 1. Identify the affected model and serial number in the subject of this letter. 2. An Olympus representative will contact you to arrange for the return of your affected device. Olympus will repair your unit free of charge. 3. Olympus will provide for a service loaner in an effort to not disrupt patient care. Please do not hesitate to contact @ 647-999-3203 or at Cynthia.Ow@Olympus.com for any additional information or support concerning this matter. |
| Quantity | 8 units |
| Distribution | US Nationwide distribution in the states of AL, FL, NC, NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.