Device product
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
Z-2449-2021
Product summary
- Event
- Event 88440
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 28849 units Total
- Official record key
device-enforcement:Z-2449-2021
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