Device product
Pentax Video Gastroscope is intended to be used with a Pentax video processor (including light source), documentation equipment, monitor, EndoTherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the upper digestive tract including the esophagus, stomach and duodenum.
Z-0318-2017
Product summary
- Event
- Event 75332
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,436 (US) and 14,488 (OUS)
- Official record key
device-enforcement:Z-0318-2017
Official wording
Reason: PENTAX Medical is initiating this field action to provide customers that have purchased the affected endoscopes with the most recent Operation and Reprocessing IFUs.
Code information: EG-1690K, EG-2490K, EG-279oI, EG-2790K, EG-2990K, EG-2990K, EG-349oK and EG-3890TK
Distribution pattern: US Nationwide and Japan
Derived failure modes
-
Unknown
PENTAX Medical is initiating this field action to provide customers that have purchased the affected endoscopes with the most recent Operation and Reprocessing IFUs.