FDA Enforcement
Class II
Ongoing
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
Recall: Z-2448-2021
·
Reported September 22, 2021
Enforcement
- Recall Number
- Z-2448-2021
- Event ID
- 88440
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Pentax of America Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 22, 2021
- Initiation Date
- July 14, 2021
- Classification Date
- September 10, 2021
- Address
- 3 Paragon Dr, N/A, Montvale, NJ, 07645-1782, United States
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
Reason
Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families
Code Info
All devices distributed by Pentax in the US between April 2014 and May 2021
Distribution
Nationwide
Quantity
28849 units Total