Z-1181-2016Class II

Puritan Bennett 980 Ventilator System, PB980 Ventilator (980xxxxxxxx). Intended to provide continuous...

Name: Z-1181-2016 Puritan Bennett 980 Ventilator System, PB980 Ventilator (980xxxxxxxx). Intended to provide continuous...
Creator: Covidien LP (formerly Nellcor Puritan Bennett Inc.)
Published: 2016-01-15
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2016-01-15 / Terminated

FDA source

Covidien LP (formerly Nellcor Puritan Bennett Inc.) began a recall of Puritan Bennett 980 Ventilator System, PB980 Ventilator (980xxxxxxxx). Intended to provide continuous ventilation for pediatric and adult patients who require... on 2016-01-15. FDA classified it as Class II and gives the reason as "Graphical user interface (GUI) unresponsive to touch and Loss of primary ventilation under certain circumstances. Covidien Respiratory and Monitoring Solutions, now a part of Medtronic, issued a field corrective action...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1181-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-15
Posted: 2016-03-17
Terminated: 2017-07-11
Recalling firm: Medtronic, Inc.
Product: Puritan Bennett 980 Ventilator System, PB980 Ventilator (980xxxxxxxx). Intended to provide continuous ventilation for pediatric and adult patients who require either invasive ventilation or non-invasive ventilation.
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: Graphical user interface (GUI) unresponsive to touch and Loss of primary ventilation under certain circumstances. Covidien Respiratory and Monitoring Solutions, now a part of Medtronic, issued a field corrective action notice for two issues on all models of Puritan Bennett 980 (PB980) ventilator.
FDA root cause: Under Investigation by firm
Action: Customers were notified via an Urgent Medical Device Safety Notification, dated February 8, 2016, on 1/14/16. The letter identified the affected device and the issues involved. Consignees are requested to forward the recall letter to anyone they may have transferred or assigned for use one of the potentially affected ventilators. Medtronic is investigating the root cause of these conditions and will provide a service update to resolve the issues as soon as corrections can be implemented. Customers are to complete the attached form and return it per the instructions to confirm receipt and understanding of the information. Questions or issues should be directed to the Technical Support Department at 800-255-6774.
Quantity in commerce: 1,864 units
Distribution: Worldwide Distribution -- US, including but not limited to the territory of Puerto Rico; and Ireland, Jordan, Saudi Arabia, Bahrain, Australia, Japan, Israel, Turkey, Chile, South Africa, Costa Rica, United Arab Emirates, Qatar, Peru, Panama, Singapore, Kuwait, Lebanon, Brazil, Mexico, Colombia, Russia, Uruguay, Slovenia, Morocco, Argentina, Egypt, and Romania.
Product codes and lots: all versions of software.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1181-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1181-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-16

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)