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

Recall Z-0318-2017 — 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 eso

U.S. FDA — Device Enforcement · United States · 2016-08-15 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0318-2017
Date of alert: 2016-08-15
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 Medical is initiating this field action to provide customers that have purchased the affected endoscopes with the most recent Operation and Reprocessing IFUs.

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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