Z-1809-2014Class II

Model Number(s): PB840 Ventilator (4-840120DIUU-XX). The product is a component of the Puritan Bennett 840...

Name: Z-1809-2014 Model Number(s): PB840 Ventilator (4-840120DIUU-XX). The product is a component of the Puritan Bennett 840...
Creator: Nellcor Puritan Bennett Inc. (dba Covidien LP)
Published: 2014-06-04
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2014-06-04 / Terminated / root cause: design

FDA source

Nellcor Puritan Bennett Inc. (dba Covidien LP) began a recall of Model Number(s): PB840 Ventilator (4-840120DIUU-XX). The product is a component of the Puritan Bennett 840 Ventilator: The Backlight Inverter Printed Circuit... on 2014-06-04. FDA classified it as Class II and gives the reason as "In the case of a loss of GUI display due to a Backlight Inverter PCBA failure, the ventilator continues to provide uninterrupted ventilatory support at the programmed settings for the patient. However, there is a loss...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1809-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-04
Posted: 2014-06-17
Terminated: 2016-07-11
Recalling firm: Medtronic, Inc.
Product: Model Number(s): PB840 Ventilator (4-840120DIUU-XX). The product is a component of the Puritan Bennett 840 Ventilator: The Backlight Inverter Printed Circuit Board (BLI PCBA) for the 9.4 Display part number 4-079056-00. The PB840 Ventilator System is intended to provide invasive or non-invasive ventilator 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: In the case of a loss of GUI display due to a Backlight Inverter PCBA failure, the ventilator continues to provide uninterrupted ventilatory support at the programmed settings for the patient. However, there is a loss of display and thus there is a necessity to move the patient to another ventilator.
Root cause tag: design
FDA root cause: Component design/selection
Action: Covidien will be issuing the Product Notification letter in 2014. Customers are requested to forward the letter to anyone they may have transferred or assigned for use one of the 9.4display configuration ventilators. Service engineers will be replacing the BLI PCBA with a new design containing the 1.0 ampere fuse and then destroying the old PCBA. Ventilators replaced with newer models under the commercial program will be returned to Covidien for disposal. Should you have any questions regarding this letter or to report any issues with the Puritan Bennett" 840 ventilator contact our Technical Support Department at 1-800-255-6774, option 4, then option 1, to ensure proper device reporting procedures are followed. Thank you for your prompt attention to this matter.
Quantity in commerce: 7371
Distribution: Worldwide Distribution - USA (nationwide) including the states: AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY and District of Columbia., and the countries of Canada and Japan.
Product codes and lots: Display part number 4-079056-00; serial number 4200000001 to 3510012377 that have a 9.4 display. Lots 1032H,1041H,1042H,1043H,1008J,1009J,1010J,1018K,1019K,1020K,1021K,1022K,1023K,1030L,1031L,1032L,1033L,1034L,1035L,

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1809-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1809-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-25	2014-06-17

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)