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

Recall Z-2329-2015 — Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality enabled) and Neonatal Models. Designed for use on Neonatal (NICU) through Adult patient populations who require respiratory support or mechanical ventilation and weigh a minimum of 0.3 kg (0.66 lb).

U.S. FDA — Device Enforcement · United States · 2015-07-16 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2329-2015
Date of alert: 2015-07-16
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Covidien LP (formerly Nellcor Puritan Bennett Inc.)
Product category: device
Product type: Devices

Reported risk: Reports in which tidal volumes reaching patients were lower than set tidal volumes in neonatal Volume Control Plus (VC+) Mode with active humidification. This situation may potentially lead to respiratory compromise if not recognized.

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

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Recall Z-2329-2015 — Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality enabled) and Neonatal Models. Designed for use on Neonatal (NICU) through Adult patient populations who require respiratory support or mechanical ventilation and weigh a minimum of 0.3 kg (0.66 lb).

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