Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GIF-1TH190 Model/Catalog Numbe
Summary
The FDA issued a Class II for Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: by Olympus Corporation of the Americas. Reason: To better define the drying procedures described in the IFU to improve the instructions for easier understanding of each drying step after human error.
Details
Source
Device Recall
External ID
Z-0498-2025
Action Date
2024-11-27
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: Model: GIF-1TH190, UDI-DI: 04953170343360, Serial #: Less than 2446103.
Quantity Affected: 1749 units
Reason for Recall
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.
Distribution
Domestic: US Nationwide Distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-09-18
Company
Center Valley, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 280 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Olympus Corporation of the Americas has 334 FDA actions in our database, including 334 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Olympus Corporation of the Americas) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Olympus Corporation of the Americas have FDA actions?
Olympus Corporation of the Americas has 334 FDA actions in our database, including 334 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0498-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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