Recall Z-0636-2017— Pentax of America Inc

Name: FDA recall Z-0636-2017
Creator: U.S. Food and Drug Administration
Published: 2016-08-15

Class II · Terminated

Class II FDA medical device recall by Pentax of America Inc, initiated 2016-08-15, terminated 2018-03-08. It names one FDA 510(k) clearance: K131855. 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.. Reason: 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)..

Recalling firm: Pentax of America Inc
Classification: Class II
Status: Terminated
Initiated: 2016-08-15
Terminated: 2018-03-08
Firm location: Montvale, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K131855 — PENTAX VIDEO COLONOSCOPES (EC FAMILY)Pentax Medical Company·cleared 2014-04-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.