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

Recall Z-2279-2016 — Ultrasound Gastroscope Product Usage: Intended to provide optical visualization of, ultrasonic Visualization of, and therapeutic access to the Upper Gastrointestinal Tract including but not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Small Bowel and underlyi

U.S. FDA — Device Enforcement · United States · 2016-04-06 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2279-2016
Date of alert: 2016-04-06
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Pentax Medical Company
Product category: device
Product type: Devices

Reported risk: Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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