FDA-Device2024-11-27Class II
Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GIF-1TH190 Model/Catalog Number: GIF-1TH190 Software Version: N/A Product Description: This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.
Hazard
To better define the drying procedures described in the IFU to improve the instructions for easier understanding of each drying step after human errors and concerns were identified when completing a Human Factors evaluation of the GIF-1TH190.
Sold states
Domestic: US Nationwide Distribution.
Affected count
1749 units
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GIF-1TH190 Model/Catalog Number: GIF-1TH190 Software Version: N/A Product Description: This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0498-2025More Olympus Corporation of the Americas recalls
- FDA-Device2026-07-22Olympus Ellik Evacuator Model 194 recalled for inadequate sterilization parameters
- FDA-Device2026-07-22Olympus Toomey Evacuator 30cc with Adaptor recalled for inadequate sterilization
- FDA-Device2026-07-22Olympus Glass Body for 194 Ellik Evacuator recalled for inadequate sterilization
- FDA-Device2026-07-22Olympus Toomey Evacuator 50cc Model 188A recalled for inadequate sterilization parameters
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