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

Recall Z-0112-2015 — Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NICU) through Adult patient populations.

U.S. FDA — Device Enforcement · United States · 2014-10-01 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0112-2015
Date of alert: 2014-10-01
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Nellcor Puritan Bennett Inc. (dba Covidien LP)
Product category: device
Product type: Devices

Reported risk: A software issue may lead to ventilator inoperative situations.

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.

Recall Z-0112-2015 — Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NICU) through Adult patient populations.

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