EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190
This recall is currently active, issued December 5, 2024. It was issued by Olympus Corporation Of The Americas.
- Recall Initiated
- October 31, 2024
- Posted
- December 5, 2024
- Recall Number
- Z-0620-2025
- Quantity
- 1,770 units
- Firm Location
- Center Valley, PA
- Official Source
- View on FDA website ↗
Reason for Recall
High-level disinfection ("HLD") with Acecide-C disinfectant in the Olympus OER-Pro Automated Endoscope Reprocessor ("AER") has been removed as a compatible reprocessing method from the Instructions for Use when reprocessing the GIF-1THI90 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE ( GIF-1TH190 ).
Distribution
US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV.
Lot / Code Info
Model Number: GIF-1TH190; UDI: 04953170343360, 04953170437014; Serial Number Range: Before 2446103 or After 2500453
Root Cause
Under Investigation by firm
Action Taken
Olympus notified consignees via letter on about 10/31/2024. Consignees were informed of the issue and of the upcoming revision of the labeling such that the GIF-1TH190 is no longer a compatible endoscope for reprocessing with Acecide-C in the OER-Pro. They were instructed that they would be contacted by their Olympus sales representative within the month to discuss potential OER-Elite and GIF-1TH190 transition programs. Additionally, they were instructed to carefully read the notification, ensure reprocessing staff and other users of the OER-Pro AER are aware of the corrective action, acknowledge receipt of the notification through the Olympus web portal, and to identify and notify recipients of the affected devices if they were further distributed.