Reported Sep 20, 2017 · Terminated
Fujifilm Endoscope Model ED-530XT Product Usage: This product is a medical endoscope for the duodenum and upper GI…
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?
- Fujifilm
- Endoscope Model ED-530XT Product UsageThis 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
- Lot codes and dates
- For Manual Code 202B1259902B, 140417-3.0-DT-US2 - 157 manuals were distributed For Manual Code 202B1237697D, 140408-5.0-DT-US2 - 103 manuals were distributed
- Amount recalled
- 260 manuals in total
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Fujifilm is reporting a corrective action due to an FDA inspection.
This product could cause temporary or reversible health problems — stop using it.
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