Reported Nov 30, 2016 · Terminated
Pentax Video Colonoscope 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 Colonoscope 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 lower digestive tract including the anus, rectum, sigmoid colon, colon and ileocecal valve.
- Lot codes and dates
Model #'s EC-2990LIEC-3490LIEC-3490LKEC-3490TLIEC-3890LIEC-3890LK and EC-3890TLK
- Amount recalled
- 5,090 (US) and 14,209 (OUS)
Where it was sold
- Nationwide
Why it was recalled
Pentax is initiating the product correction of several model numbers of Pentax's Colonoscope that were shipped between the clearance date of April 2014 and September 2015 because they contain the operation and reprocessing IFU's that were in use prior to the 2014 clearances and therefore did not include the cleared operation IFU, the updated reprocessing IFU or the dedicated reprocessing adaptor (for applicable models).
This product could cause temporary or reversible health problems — stop using it.
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