Device product
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
Z-2448-2021
Product summary
- Event
- Event 88440
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 28849 units Total
- Official record key
device-enforcement:Z-2448-2021
Official wording
Reason: Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families
Code information: All devices distributed by Pentax in the US between April 2014 and May 2021
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families