FUJINON ED-530XT. This device is intended for the recall: Labeling Error
FUJINON ED-530XT. This device is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation…
Why was FUJINON ED-530XT. This device is intended for the recalled?
An update to the design and labeling was implemented to help reduce patient risk associated with inadequate reprocessing of the device. The action includes replacement of the forceps elevator mechanism, the O-ring seal, the distal end cap and issuance of a new Operation Manual.
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?
All lots/serial numbers
- Product
- FUJINON ED-530XT. This device is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation…
- Recalling firm
- Fujifilm Medical Systems U.S.A., Inc.
- Quantity
- 362 units
- Distribution
- Nationwide
- Recall date
- October 4, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)