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.
- Company
- Pentax Of America Inc
- Recall Initiated
- August 15, 2016
- Posted
- October 26, 2016
- Terminated
- April 23, 2019
- Recall Number
- Z-0318-2017
- Quantity
- 3,436 (US) and 14,488 (OUS)
- Firm Location
- Montvale, NJ
Reason for Recall
PENTAX Medical is initiating this field action to provide customers that have purchased the affected endoscopes with the most recent Operation and Reprocessing IFUs.
Distribution
US Nationwide and Japan
Lot / Code Info
EG-1690K, EG-2490K, EG-279oI, EG-2790K, EG-2990K, EG-2990K, EG-349oK and EG-3890TK
Root Cause
Labeling Change Control
Action Taken
Pentax sent as "Urgent Field Correction" and Field Correction Response Form dated August 15, 2016 to their affected customers.
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