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

Recall Z-1439-2020 — bellavista 1000 ventilator, Catalog number 301.100.030. bellavista is an electronically controlled pneumatic ventilation system with an integrated air compressing system. bellavista uses room air and high-pressure oxygen. Air enters through a fresh gas intake port and is compressed together with

U.S. FDA — Device Enforcement · United States · 2019-11-25 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1439-2020
Date of alert: 2019-11-25
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Vyaire Medical
Product category: device
Product type: Devices

Reported risk: The G6 bellavista 1000 US ventilators may experience intermittent failures: Lack of acoustic high priority alarm, presence of a 'no alarm' condition, or presence of non-responsive touch screen.

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

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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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