Z-2329-2015Class I

Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality enabled) and Neonatal Models...

Name: Z-2329-2015 Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality enabled) and Neonatal Models...
Creator: Covidien LP (formerly Nellcor Puritan Bennett Inc.)
Published: 2015-07-16
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2015-07-16 / Terminated / root cause: software

FDA source

Covidien LP (formerly Nellcor Puritan Bennett Inc.) began a recall of Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality enabled) and Neonatal Models. Designed for use on Neonatal (NICU) through Adult... on 2015-07-16. FDA classified it as Class I and gives the reason as "Reports in which tidal volumes reaching patients were lower than set tidal volumes in neonatal Volume Control Plus (VC+) Mode with active humidification. This situation may potentially lead to respiratory compromise if...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2329-2015
Classification: Class I
Status: Terminated
Initiated: 2015-07-16
Posted: 2015-08-14
Terminated: 2016-06-02
Recalling firm: Medtronic, Inc.
Product: Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality enabled) and Neonatal Models. Designed for use on Neonatal (NICU) through Adult patient populations who require respiratory support or mechanical ventilation and weigh a minimum of 0.3 kg (0.66 lb).
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: Reports in which tidal volumes reaching patients were lower than set tidal volumes in neonatal Volume Control Plus (VC+) Mode with active humidification. This situation may potentially lead to respiratory compromise if not recognized.
Root cause tag: software
FDA root cause: Software design
Action: Consignees will be notified via letter on July 17, 2015. No products will be returned, the reconfiguration of affected ventilators will occur at customer sites.
Quantity in commerce: 657 units
Distribution: Worldwide Distribution-US (nationwide) and the countries of Canada, United Arab Emirates, Argentina, Australia, Bahrain, Brazil, Chile, Colombia, Costa Rica, Egypt, Ireland, Israel, Jordan, Japan, Kuwait, Lebanon, Morocco, Mexico, Panama, Peru, Qatar, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Turkey, and Uruguay.
Product codes and lots: PB980 Ventilator (980xxxxxxxx): 980U1ENDIUU, 980U1ENDIUUS, 980U3ENDIUU, 980U3ENDIUUS, 980N1ENDIUU, 980N1ENDIUUS, 980N3ENDIUU, 980N3ENDIUUS

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2329-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2329-2015	Class I	Terminated	Voluntary: Firm initiated	2015-08-26	2015-08-14

Product code CBK

K131252Class IIPuritan Bennett 980 Series Ventilator SystemCovidien / cleared 2014-02-24

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)