Recall Z-2449-2021 ยท FDF Colonoscope And Accessories, Flexible/Rigid
Pentax of America Inc
Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-2790i, EG-1690K, EG-2490K, EG-2790K, EG27-i10; Gastroscope Family # 2- Gastroscopes with a Water Jet Channel Models: EG-2990i, EG-2990K, EG-3490K, EG29-i10; Gastroscope Family # 3-Gastroscopes with Two Instrument Channels and a Water Jet Channel Models: EG-3890TK
| Date | Jul 14, 2021 |
| Status | Open, Classified |
| Reason | Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families |
| Root cause | Device Design |
| Action | Pentax issued Urgent Medical Device Correction letter via UPS mailing on 7/14/21. Letter states reason for recall, health risk and action to take (USB drive along with the enclosed instruction sheet enclosed). Letter states: PENTAX separated the EC and EG rIFUs into 5 separate rIFUs . The grouping will allow the following for reprocessing personnel: " Eliminate the need to identify optional configurations of instrument channels and water jet channels " Simplify the instructions and graphics in the individual rIFUs Please replace any previous versions of rIFUs with the most current revision. |
| Quantity | 28849 units Total |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |