Recall Z-2448-2021 ยท FDF Colonoscope And Accessories, Flexible/Rigid
Pentax of America Inc
Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel and a Water Jet Channel Models: EC-2990Li, EC-3490Li, EC-3890Li, EC-3490TLi, EC-3490LK, EC-3890LK, EC3890LZi, EC34-i10L, EC38-i10L; Colonoscope Family # 2-Pentax Video Colonoscopes with Two Instrument Channels and a Water Jet Channel Model: EC-3890TLK
| 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 |