FDAFDA · Food and drugs·Recall number Z-1058-2015
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.
Published February 11, 2015 · Recall initiated: January 12, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Covidien LP (formerly Nellcor Puritan Bennett Inc.)
- Distributor
- Worldwide Distribution - USA (nationwide) and Internationally to Canada.
- Lot
- All Puritan Bennett 980 ventilators
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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