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

Recall Z-0425-2021 — Puritan Bennett 980 (PB980) Ventilator Series - Product Usage: for use on patient population sizes from Neonatal (NICU) through Adult who require respiratory support or mechanical ventilation SKU: 980X1ENDIUU 980X1ENDIUU 980X3FRAIQC 980X3DEDRAC 980X3ENNISB 980X3NLDRAC 980X3PLDIPC 980X3ESDIE

U.S. FDA — Device Enforcement · United States · 2020-10-16 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0425-2021
Date of alert: 2020-10-16
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Covidien Llc
Product category: device
Product type: Devices

Reported risk: In-house lab observations and customer reports of overheating and/or thermal damage to the battery pack, create the risk of exposure to smoke or hazardous materials, which may result in burns and/or bronchospasm,

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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