EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model: GIF-HQ190
- Recall Initiated
- April 22, 2022
- Recall Number
- Z-1275-2022
- Quantity
- 8 units
- Firm Location
- Center Valley, PA
Reason for Recall
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
Distribution
US Nationwide distribution in the states of AL, FL, NC, NY.
Lot / Code Info
UDI-DI: 04953170305276 Serial: 2269931, 2611873, 2613235, 2634251, 2634326, 2860721, 2961773 and 2962545
Root Cause
Nonconforming Material/Component
Action Taken
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.