FDAFDA · Food and drugs·Recall number Z-3129-2017
Fujifilm Endoscope Models ED-250XL5 ED-250XT5 ED-450XT5 ED-450XL5 Product Usage: This product is a medical endoscope for the duodenum and upper GI tract. It is intended for observation, diagnosis, and endoscopic treatment of the esophagus, stomach and duodenum. This product is not used for any other purposes.
Published September 20, 2017 · Recall initiated: March 9, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Fujifilm is conducting a corrective action due to an FDA inspection.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Fujifilm Medical Systems U.S.A., Inc.
- Distributor
- US Nationwide Distribution
- Lot
- will be entered.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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