Covidien LP (formerly Nellcor Puritan Bennett Inc.) recalls Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxxx), The Puritan BennettTM 980 Ventilat

Recalled February 11, 2015 · FDA recall Z-1058-2015 · Covidien LP (formerly Nellcor Puritan Bennett Inc.)

Hazard

Covidien is issuing a voluntary field action for all Puritan Bennett 980 ventilators due to occasional GUI transient resets that last approximately 30 seconds. · FDA Class II

Units

418 units

Sold at

Worldwide Distribution - USA (nationwide) and Internationally to Canada.

Description

Covidien is issuing a voluntary field action for all Puritan Bennett 980 ventilators due to occasional GUI transient resets that last approximately 30 seconds.

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.

Manufacturer(s)

Covidien LP (formerly Nellcor Puritan Bennett Inc.)

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →