FDA Enforcement
Class II
Terminated
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.
Recall: Z-0318-2017
·
Reported November 2, 2016
Enforcement
- Recall Number
- Z-0318-2017
- Event ID
- 75332
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Pentax of America Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 2, 2016
- Initiation Date
- August 15, 2016
- Classification Date
- October 26, 2016
- Termination Date
- April 23, 2019
- Address
- 3 Paragon Dr, Montvale, NJ, 07645-1782, United States
Description
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.
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 Info
EG-1690K, EG-2490K, EG-279oI, EG-2790K, EG-2990K, EG-2990K, EG-349oK and EG-3890TK
Distribution
US Nationwide and Japan
Quantity
3,436 (US) and 14,488 (OUS)