GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI 04953170305276 Serial Numbers 2270393, 2201027, 2201611, 2745407
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Aizu Olympus Co., Ltd.
- Reason for Recall:
- Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
Product Codes/Lot Numbers:
UDI-DI 04953170305276 Serial Numbers 2270393, 2201027, 2201611, 2745407
Distribution:
Distributed in: FL, KY, MA, NJ, NY, PA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0417-2024
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