FDA Recall
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
·
Initiated August 15, 2016
Recall
- Recall Number
- Z-0318-2017
- Event Number
- 75332
- Firm
- Pentax of America Inc
- FEI Number
- 1000080301
- Product Code
- FDS
- Status
- Terminated
- Root Cause
- Labeling Change Control
- Initiated
- August 15, 2016
- Posted
- October 26, 2016
- Terminated
- April 23, 2019
- Address
- 3 Paragon Dr, Montvale, NJ, 07645-1782
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.
Action
Pentax sent as "Urgent Field Correction" and Field Correction Response Form dated August 15, 2016 to their affected customers.
Distribution
US Nationwide and Japan
Quantity
3,436 (US) and 14,488 (OUS)