Pentax of America Inc Recall 88440
Description: 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
Pentax of America Inc Recall 88440 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2449-2021 |
| Event ID | 88440 |
| Event Description | 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 |
| Product Type | Devices |
| Distribution | Nationwide |
| Quantity | 28849 units Total |
| Recall Reason | Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families |
| Device Classification | 20210922 |
| Device Code Info | All devices distributed by Pentax in the US between April 2014 and May 2021 |
| Center Classification Date | 20210910 |
| Recall Initiation Date | 20210714 |
| Recalling Firm | Pentax of America Inc |
| Initial Notification | Letter |
| Similar To |