Reported Nov 2, 2016 · Terminated
Pentax Video Gastroscope is intended to be used with a Pentax video processor (including light source), documentation…
Pentax of 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: Pentax of America Inc · 3 Paragon Dr · Montvale, NJ · 07645-1782
Is this the product you have?
- Pentax Video Gastroscope is intended to be used with a Pentax video processor (including light source), documentation equipment, monitor, EndoTherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the upper digestive tract including the esophagus, stomach and duodenum.
- Lot codes and dates
EG-1690KEG-2490KEG-279oIEG-2790KEG-2990KEG-2990KEG-349oK and EG-3890TK
- Amount recalled
- 3,436 (US) and 14,488 (OUS)
Where it was sold
- Nationwide
Why it was recalled
PENTAX Medical is initiating this field action to provide customers that have purchased the affected endoscopes with the most recent Operation and Reprocessing IFUs.
This product could cause temporary or reversible health problems — stop using it.
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