Fujifilm Medical Endoscope for the duodenum and upper recall
Fujifilm Medical Endoscope for the duodenum and upper G.I. tract. ED-530XT, ED-250XT5, ED-250XL5, ED-450XT5, and ED-450XL5 Endoscope Operation…
Why was Fujifilm Medical Endoscope for the duodenum and upper recalled?
The suction button on the ED-530XT endoscope may become lodged (stuck) in the active position following the use of x-ray contrast agents during ERCP procedures.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
ED-530XT - Part #202B1237697D; ED-250XT5 and ED-250XL5 - Part #202B1260196A; ED-450XT5 - Part #202B1260211A and ED-450XL5 - Part #202B1237681
- Product
- Fujifilm Medical Endoscope for the duodenum and upper G.I. tract. ED-530XT, ED-250XT5, ED-250XL5, ED-450XT5, and ED-450XL5 Endoscope Operation…
- Recalling firm
- Fujifilm Medical Systems U.S.A., Inc.
- Quantity
- 256 units
- Distribution
- Distributed in the US and Canada.
- Recall date
- September 23, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)