Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model Numbers: GIF-1TH190, GIF-1TQ160, GIF-2T160, GIF-2TH180, GIF-H170, GIF-H180, GIF-H180J, GIF-H190, GIF-HQ190, GIF-LV1, GIF-N180, GIF-Q150, GIF-Q160Z, GIF-Q180, GIF-XP180N, GIF-XP190N, GIF-XTQ160. 510(k) Numbers: K112680, K954451, K051645, K100584, K111756, K011151, K123317.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model Numbers: GIF-1TH190 (04953170343360), GIF-1TQ160 (Not recorded), GIF-2T160 (04953170307492), GIF-2TH180 (04953170339745), GIF-H170 (04953170334115), GIF-H180 (04953170339769), GIF-H180J (04953170307539), GIF-H190 (04953170305290), GIF-HQ190 (04953170305276), GIF-LV1 (04953170312373), GIF-N180 (04953170307508), GIF-Q150 (04953170307485), GIF-Q160Z (04953170066795), GIF-Q180 (04953170307522), GIF-XP180N (04953170307515), GIF-XP190N (04953170305313), GIF-XTQ160 (04953170339837).
- 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:
- Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model Numbers: GIF-1TH190, GIF-1TQ160, GIF-2T160, GIF-2TH180, GIF-H170, GIF-H180, GIF-H180J, GIF-H190, GIF-HQ190, GIF-LV1, GIF-N180, GIF-Q150, GIF-Q160Z, GIF-Q180, GIF-XP180N, GIF-XP190N, GIF-XTQ160. 510(k) Numbers: K112680, K954451, K051645, K100584, K111756, K011151, K123317.
Product Codes/Lot Numbers:
Model Numbers: GIF-1TH190 (04953170343360), GIF-1TQ160 (Not recorded), GIF-2T160 (04953170307492), GIF-2TH180 (04953170339745), GIF-H170 (04953170334115), GIF-H180 (04953170339769), GIF-H180J (04953170307539), GIF-H190 (04953170305290), GIF-HQ190 (04953170305276), GIF-LV1 (04953170312373), GIF-N180 (04953170307508), GIF-Q150 (04953170307485), GIF-Q160Z (04953170066795), GIF-Q180 (04953170307522), GIF-XP180N (04953170307515), GIF-XP190N (04953170305313), GIF-XTQ160 (04953170339837).
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0334-2024
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