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

Recall Z-2077-2016 — Ultrasound Gastroscope Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Upper Gastrointestinal Track including but not restricted to organs, tissues and subsystems: Esophagus, Stomach, Duodenum, Small Bowel and underlying areas. The instrument

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-2077-2016
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 has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.

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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