Recall Z-0636-2017 ยท FDF Colonoscope And Accessories, Flexible/Rigid
Pentax of America Inc
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.
| Date | Nov 19, 2016 (initiated Aug 15, 2016) |
| Status | Terminated |
| 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). |
| Root cause | Other |
| Action | Pentax sent as "Urgent Field Correction" and Field Correction Response Form dated August 15, 2016 to their affected customers. |
| Quantity | 5,090 (US) and 14,209 (OUS) |
| Distribution | US Nationwide and Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131855 | PENTAX VIDEO COLONOSCOPES (EC FAMILY) Pentax Medical Company, Apr 9, 2014 |