RecallRadar

FDA Device recall Z-1844-2014

Puritan Bennett 840 Ventilator (4-840120DIUU-XX) The PB840 Ventilator System is intended to provide invasive or non-invasive ventilatory su…

On 2014-07-02 the FDA classified a Class II recall of Puritan Bennett 840 Ventilator (4-840120DIUU-XX) The PB840 Ventilator System is intended to provide invasive or non-invasive ventilatory su… by Nellcor Puritan Bennett Dba Covidien, citing 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 inf….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1844-2014
ClassificationClass II
Statusterminated
Initiated2014-06-03
Published2014-07-02
Last updated2026-09-13 11:53 UTC
CompanyNellcor Puritan Bennett Dba Covidien
DistributionUS

Product

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 facilities.

Reason

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.

Identifiers

code_infoserial number 3510100714 to 3512101160 and any units in which a replacement PSU was installed between March 2010 and September of 2010.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1844-2014%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.