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

Recall Z-1844-2014 — Puritan Bennett 840 Ventilator (4-840120DIUU-XX) The PB840 Ventilator System is intended to provide invasive or non-invasive ventilatory support and monitoring for infant, pediatric, and adult patients with respiratory failure or respiratory insufficiency. It is used in hospitals and healthcare f

U.S. FDA — Device Enforcement · United States · 2014-06-03 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1844-2014
Date of alert
2014-06-03
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Nellcor Puritan Bennett Inc. (dba Covidien LP)
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
3510100714
Reported risk: Covidien is conducting a medical device field correction for specific Puritan Bennett 840 Ventilators due to customer reports of loss of graphical user interface (GUI) display information while the ventilator continues to provide breath support.
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.