Reported Oct 4, 2017 · Terminated
FUJINON ED-530XT. This device is intended for the visualization of the duodenum and upper digestive tract, specifically…
Fujifilm Medical Systems U.S.A., Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fujifilm Medical Systems U.S.A., Inc. · 10 Highpoint Dr · Wayne, NJ · 07470-7431
Is this the product you have?
- FUJINON ED-530XT. This device is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
- Lot codes and dates
- All lots/serial numbers
- Amount recalled
- 362 units
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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