Z-1844-2014Class II

Puritan Bennett 840 Ventilator (4-840120DIUU-XX) The PB840 Ventilator System is intended to provide invasive...

Name: Z-1844-2014 Puritan Bennett 840 Ventilator (4-840120DIUU-XX) The PB840 Ventilator System is intended to provide invasive...
Creator: Nellcor Puritan Bennett Inc. (dba Covidien LP)
Published: 2014-06-03
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2014-06-03 / Terminated / root cause: manufacturing process

FDA source

Nellcor Puritan Bennett Inc. (dba Covidien LP) began a recall of Puritan Bennett 840 Ventilator (4-840120DIUU-XX) The PB840 Ventilator System is intended to provide invasive or non-invasive ventilatory support and monitoring... on 2014-06-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1844-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-03
Posted: 2014-06-20
Terminated: 2016-08-22
Recalling firm: Medtronic, Inc.
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.
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Covidien sent an Urgent Medical Device Voluntary Field Correction letter dated 6/13/2014, to all affected customers. The letter identified the product the problem and and the action needed to be taken by the customer. Customers are requested to forward the recall letter to anyone they may have transferred or assigned for use one of the potentially affected ventilators. Service professionals will be identifying the affected PSUs and replacing them. The removed PSUs will be destroyed. To verify whether your devices are affected by this field safety corrective action and to initiate the process to receive the actions mentioned above, please complete the attached verification form and fax it to the Covidien contact indicated on the form. If you need further assistance, contact our Technical Support Department @ 1-800-255-6774, option 4, then option 1.
Quantity in commerce: 104
Distribution: Worldwide Distribution - USA (nationwide) including Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY., and the countries of Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, Egypt, Germany, Guatemala, Israel, Japan, Kazakhstan, Kenya, Lebanon, Libya, Macedonia, Mexico, Montenegro, Morocco, Panama, Peru, Russia, Saudi Arabia, Singapore, Switzerland, Taiwan, Tunisia, Turkey, Yugoslavia (Serbia & Montenegro) Including GOVT/VA/Military
Product codes and lots: serial number 3510100714 to 3512101160 and any units in which a replacement PSU was installed between March 2010 and September of 2010.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1844-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1844-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-20

Product code CBK

K970460Class IINellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. / cleared 1998-04-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)