Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2713-2017 — Video Duodenoscope These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to, the biliary tract via the upper GI tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: esophagus, stomach, duodenum, com

U.S. FDA — Device Enforcement · United States · 2017-01-17 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2713-2017
Date of alert
2017-01-17
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Pentax of America Inc
Product category
device
Product type
Devices
Reported risk: Pentax initiated a field correction/safety alert for two (2) models of the Video Duodenoscope to determine how soiling may have occurred on the surface of the suction cylinder and under the distal cap during testing.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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