Recall Z-0498-2025 ยท FDS Gastroscope And Accessories, Flexible/Rigid
Olympus Corporation of the Americas
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 end
| Date | Nov 20, 2024 (initiated Sep 18, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Reprocessing Controls |
| Action | On October 18, 2024 URGENT: MEDICAL DEVICE CORRECTION letters were sent to customers. Actions Required: Our records indicate that your facility has purchased one or more of the affected products. The range of affected serial numbers is included at the top of this letter. Olympus requires you to take the following actions: 1. Carefully read the content of this notification. 2. Implement use of the enclosed Addendum stating that the channel drying time has been extended by 12 minutes to purge water from the channels. This is accomplished by drying each channel for 3 minutes, in the sequence des |
| Quantity | 1749 units |
| Distribution | Domestic: US Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K232997 | EVIS Exera III Gastrointestinal Videoscope GIF-1TH190 Olympus Medical Systems Corporation, Jun 19, 2024 |