Recall Z-0318-2017 ยท FDS Gastroscope And Accessories, Flexible/Rigid
Pentax of America Inc
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.
| Date | Oct 26, 2016 (initiated Aug 15, 2016) |
| Status | Terminated |
| Reason | PENTAX Medical is initiating this field action to provide customers that have purchased the affected endoscopes with the most recent Operation and Reprocessing IFUs. |
| Root cause | Labeling Change Control |
| Action | Pentax sent as "Urgent Field Correction" and Field Correction Response Form dated August 15, 2016 to their affected customers. |
| Quantity | 3,436 (US) and 14,488 (OUS) |
| Distribution | US Nationwide and Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131902 | PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY) Pentax Medical Company, Apr 10, 2014 |