Z-0497-2019Class I

Puritan Bennett 980 (PB980) ventilator series: Puritan Bennett" 980 Pediatric Adult Ventilator Puritan...

Name: Z-0497-2019 Puritan Bennett 980 (PB980) ventilator series: Puritan Bennett" 980 Pediatric Adult Ventilator Puritan...
Creator: Covidien Llc
Published: 2018-09-18
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2018-09-18 / Terminated / root cause: design

FDA source

COVIDIEN LLC began a recall of Puritan Bennett 980 (PB980) ventilator series: Puritan Bennett" 980 Pediatric Adult Ventilator Puritan Bennett" 980 Neonatal Ventilator Puritan Bennett" 980... on 2018-09-18. FDA classified it as Class I and gives the reason as "Software Update: External USB Drive performance and its impact on Graphic User Interface (GUI) functionality and labeling of the scalar waveform displayed on GUI during ventilation". 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-0497-2019
Classification: Class I
Status: Terminated
Initiated: 2018-09-18
Posted: 2018-12-18
Terminated: 2021-02-01
Recalling firm: Medtronic, Inc.
Product: Puritan Bennett 980 (PB980) ventilator series: Puritan Bennett" 980 Pediatric Adult Ventilator Puritan Bennett" 980 Neonatal Ventilator Puritan Bennett" 980 Universal Ventilator Product Usage: The Puritan Bennett 980 Series Ventilator is designed for use on patient population sizes from Neonatal (NICU) through Adult who require respiratory support or mechanical ventilation and weigh a minimum of 0.3 kg (0.66 lb). It is suitable for service in hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilatory support using medical oxygen and compressed medical air from either an internal air compressor or external air sources to deliver oxygen concentrations of 21% to 100%. Ventilatory support can be delivered invasively or non-invasively, to patients who require the followingtypes 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: Software Update: External USB Drive performance and its impact on Graphic User Interface (GUI) functionality and labeling of the scalar waveform displayed on GUI during ventilation
Root cause tag: design
FDA root cause: Device Design
Action: Medtronic notified U.S. consignees notified via Federal Express or certified mail on September 19, 2018, and the letter informs customers that Medtronic has developed a software update, Maintenance Release (MR) 5.4. Medtronic Service Engineers will load the MR5.4 software during the next scheduled or planned maintenance visit. Immediately notify all care environments in which the PB980 ventilators are used about this notification. " If your facility has distributed PB980 ventilators to other persons or facilities, please promptly forward a copy of this letter to those recipients. " Complete the attached form and return it as directed to confirm your receipt and understanding of this information. Any incidents related to this issue or if you have any questions, please contact our Technical Support Department immediately at 1-800-255-6774. Out--Side US accounts notified by Medtronic Regulatory Partners worldwide on 9/17/18 for translation in their respective country.
Quantity in commerce: 9,593
Distribution: Worldwide Distribution - US Nationwide Foreign: Canada Argentina Chile Japan Hong Kong Taiwan Uruguay Austria Austria Azerbaijan Belgium Bosnia And Herzegovina Bulgaria Croatia Czech Republic France Germany Greece Hungary Ireland Israel Italy Kazakhstan Kenya Kuwait Latvia Lebanon Lithuania Netherlands Oman Pakistan Poland Portugal Romania Russian Federation Saudi Arabia Slovakia Slovenia South Africa Spain Sweden Switzerland Tunisia Turkey United Arab Emirates Iran United Kingdom
Product codes and lots: Serial Numbers: 35B1300001 through 35B1300051 35B1400003 through 35B1402216 35B1500001 through 35B1502227 35B1600001 through 35B1601408 35B1700001 through 35B1702519 35B1800001 through 35B1801541 35B1400001 35B1601182, 35B1601183, 35B1601193, 35B1601197, 35B1601242 35B1601243, 35B1601245, 35B1702479, 35B1601001, 35B1601089

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0497-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0497-2019	Class I	Terminated	Voluntary: Firm initiated	2018-12-26	2018-12-18

Product code CBK

K162738Class IIPuritan Bennett 980 Ventilator SystemCovidien / cleared 2017-10-27

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)