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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.

FDA Recall Z-0318-2017 · Posted 2016-10-26

Recalling FirmPentax of America Inc
Recall StatusTerminated
Product CodeFDS
Date Initiated2016-08-15
Date Terminated2019-04-23
Product Quantity3,436 (US) and 14,488 (OUS)

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.

Firm Action

Pentax sent as "Urgent Field Correction" and Field Correction Response Form dated August 15, 2016 to their affected customers.

Root Cause

Labeling Change Control

Distribution Pattern

US Nationwide and Japan

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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