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

Recall Z-0497-2019 — Puritan Bennett 980 (PB980) ventilator series: Puritan Bennett" 980 Pediatric Adult Ventilator Puritan Bennett" 980 Neonatal Ventilator Puritan Bennett" 980 Universal Ventilator Product Usage: The Puritan Bennett 980 Series Ventilator is designed for use on patient population sizes from Ne

U.S. FDA — Device Enforcement · United States · 2018-09-18 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0497-2019
Date of alert: 2018-09-18
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: COVIDIEN LLC
Product category: device
Product type: Devices

Reported risk: Software Update: External USB Drive performance and its impact on Graphic User Interface (GUI) functionality and labeling of the scalar waveform displayed on GUI during ventilation

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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