Recall Z-0620-2025— Olympus Corporation of the Americas
Class II · Ongoing
Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2024-10-31. It names one FDA 510(k) clearance: K232997. Product: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190. Reason: 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 )..
- Recalling firm
- Olympus Corporation of the Americas
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-10-31
- Firm location
- Center Valley, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190
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 ).
Data sourced from openFDA. This site is unofficial and independent of the FDA.