Home / Recalls / Covidien LP (formerly Nellcor Puritan Bennett Inc.) / Z-1181-2016

Z-1181-2016 Class II Terminated

Recalled by Covidien LP (formerly Nellcor Puritan Bennett Inc.) — Boulder, CO

FDA device recall Z-1181-2016 was initiated by Covidien LP (formerly Nellcor Puritan Bennett Inc.) on January 15, 2016 and is designated Class II. 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 fiel… The recall status is terminated (terminated July 11, 2017). Affected quantity: 1,864 units.

Recall Details

Product Type: Devices
Report Date: March 23, 2016
Initiation Date: January 15, 2016
Termination Date: July 11, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1,864 units

Product Description

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.

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.

Distribution Pattern

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.

Code Information

all versions of software.

Other recalls by Covidien LP (formerly Nellcor Puritan Bennett Inc.)

Z-2329-2015 Class I — Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality en (July 16, 2015)
Z-2267-2015 Class II — OxiMax N-65 Handheld Pulse Oximeter. N65, N65-1, N65P, and N65P-1. For cont (June 29, 2015)
Z-2268-2015 Class II — OxiMax N-560 Pulse Oximeter. For continuous or spot check monitoring of functio (June 29, 2015)
Z-1951-2015 Class I — Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard (May 8, 2015)
Z-1950-2015 Class I — Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube, Cuffless. Mode (May 8, 2015)
Z-1058-2015 Class II — Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxxx), (January 12, 2015)