Z-1058-2015Class II

Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxxx), The Puritan BennettTM 980...

Name: Z-1058-2015 Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxxx), The Puritan BennettTM 980...
Creator: Covidien LP (formerly Nellcor Puritan Bennett Inc.)
Published: 2015-01-12
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2015-01-12 / Terminated / root cause: software

FDA source

Covidien LP (formerly Nellcor Puritan Bennett Inc.) began a recall of Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxxx), The Puritan BennettTM 980 Ventilator System is designed for use on Neonatal... on 2015-01-12. FDA classified it as Class II and gives the reason as "Covidien is issuing a voluntary field action for all Puritan Bennett 980 ventilators due to occasional GUI transient resets that last approximately 30 seconds". 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-1058-2015
Classification: Class II
Status: Terminated
Initiated: 2015-01-12
Posted: 2015-02-05
Terminated: 2016-01-06
Recalling firm: Medtronic, Inc.
Product: Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxxx), The Puritan BennettTM 980 Ventilator System is 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). It is suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator support, delivered invasively or noninvasively, to patients who require the following types of ventilator support: "Positive Pressure Ventilation, delivered invasively (via endotracheal tube or trach tube) or non-invasively (via mask or nasal prongs) "Assist/ Control, SIMV or Spontaneous modes of ventilation.
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: Covidien is issuing a voluntary field action for all Puritan Bennett 980 ventilators due to occasional GUI transient resets that last approximately 30 seconds.
Root cause tag: software
FDA root cause: Software design
Action: Covidien sent an Urgent Field Safety Notice on January 12, 2015, to all affected customers. Customers were requested to forward the recall letter to anyone they may have transferred or assigned for use one of the potentially affected ventilators. Covidien is updating software that will modify ventilator alarms and status display messages during a GUI reset. The Puritan Bennett 980 Ventilator Operator Manual will be updated to delete,replace ventilator during a GUI transient reset, and to inform users to monitor the secondary status display until the primary display refreshes. Covidien will communicate with customers when the software and operator manual updates are available. Customers with questions were instructed to contact Technical Support Department at 800-255-6774, option 4, and then option 1. For questions regarding this recall call 303-876-8870.
Quantity in commerce: 418 units
Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Canada.
Product codes and lots: All Puritan Bennett 980 ventilators

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1058-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1058-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-11	2015-02-05

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)