Reported Sep 30, 2015 · Terminated
EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V. This instrument has been designed to be used with an Olympus…
Olympus America 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: Olympus America Inc. · 3500 Corporate Pkwy. · Center Valley, PA · 18034-0610
Is this the product you have?
- EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V. This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.
- Lot codes and dates
- ModelTJF-Q180V, all sold units
- Amount recalled
- 6109
Where it was sold
- Nationwide
Why it was recalled
New and validated reprocessing procedures have been issued for the Olympus TJF-Q180V duodenoscope ("TJF-Q180V"), consisting of revised manual cleaning and high level disinfection procedures.
This product could cause temporary or reversible health problems — stop using it.
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