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.
Reported: September 20, 2017 Initiated: March 9, 2015 #Z-3129-2017
Product Description
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.
Reason for Recall
Fujifilm is conducting a corrective action due to an FDA inspection.
Details
- Recalling Firm
- Fujifilm Medical Systems U.S.A., Inc.
- Units Affected
- 260 manuals in total
- Distribution
- US Nationwide Distribution
- Location
- Wayne, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Fujifilm Medical Systems U.S.A., Inc.. Units affected: 260 manuals in total.
Why was this product recalled? ▼
Fujifilm is conducting a corrective action due to an FDA inspection.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 20, 2017. Severity: Moderate. Recall number: Z-3129-2017.
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