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Open, Classified

EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model: GIF-HQ190

FDA Recall Z-1275-2022 · Posted None

Recalling FirmOlympus Corporation of the Americas
Recall StatusOpen, Classified
Product CodeFDS
Date Initiated2022-04-22
Product Quantity8 units

Reason for Recall

Part (A-rubber) intended for a different model of gastrointestinal videoscope may have been used when replacing part on GIF-HQ190 during the last repair at Olympus. An Incorrect A-rubber fits tighter on the GIF-HQ190 which would not meet the intended design specifications

Firm Action

Olympus issued Urgent Medical Device Correction letter via email on 4/22/22. Letter states reason for recall, health risk and action to take: 1. Identify the affected model and serial number in the subject of this letter. 2. An Olympus representative will contact you to arrange for the return of your affected device. Olympus will repair your unit free of charge. 3. Olympus will provide for a service loaner in an effort to not disrupt patient care. Please do not hesitate to contact @ 647-999-3203 or at [email protected] for any additional information or support concerning this matter.

Root Cause

Nonconforming Material/Component

Distribution Pattern

US Nationwide distribution in the states of AL, FL, NC, NY.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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