Recall Z-0318-2017— Pentax of America Inc

Name: FDA recall Z-0318-2017
Creator: U.S. Food and Drug Administration
Published: 2016-08-15

Class II · Terminated

Class II FDA medical device recall by Pentax of America Inc, initiated 2016-08-15, terminated 2019-04-23. It names one FDA 510(k) clearance: K131902. 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.. 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..

Recalling firm: Pentax of America Inc
Classification: Class II
Status: Terminated
Initiated: 2016-08-15
Terminated: 2019-04-23
Firm location: Montvale, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K131902 — PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY)Pentax Medical Company·cleared 2014-04-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product 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 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.