Pentax of America Inc Recall 88440
Description: 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
Pentax of America Inc Recall 88440 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2448-2021 |
| Event ID | 88440 |
| Event Description | 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 |
| 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 |
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