Recall Z-0636-2017
Pentax of America Inc · initiated August 15, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Model #'s EC-2990LI, EC-3490LI, EC-3490LK, EC-3490TLI, EC-3890LI, EC-3890LK and EC-3890TLK
Reason for recall
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).
FDA-determined cause: Other
Action taken
Pentax sent as "Urgent Field Correction" and Field Correction Response Form dated August 15, 2016 to their affected customers.
Details
- Recall number
- Z-0636-2017
- Initiated
- August 15, 2016
- Posted by FDA
- November 19, 2016
- Terminated
- March 8, 2018
- Product code
- FDF – Colonoscope And Accessories, Flexible/Rigid
- Quantity
- 5,090 (US) and 14,209 (OUS)
- Distribution
- US Nationwide and Japan
- Recalling firm
- Pentax of America Inc, Montvale, NJ