Z-1058-2015 Class II Terminated
FDA device recall Z-1058-2015 was initiated by Covidien LP (formerly Nellcor Puritan Bennett Inc.) on January 12, 2015 and is designated Class II. Reason for recall: Covidien is issuing a voluntary field action for all Puritan Bennett 980 ventilators due to occasional GUI transient resets that last approximately 30 seconds. The recall status is terminated (terminated January 6, 2016). Affected quantity: 418 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 11, 2015
- Initiation Date
- January 12, 2015
- Termination Date
- January 6, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 418 units
Product Description
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.
Reason for Recall
Covidien is issuing a voluntary field action for all Puritan Bennett 980 ventilators due to occasional GUI transient resets that last approximately 30 seconds.
Distribution Pattern
Worldwide Distribution - USA (nationwide) and Internationally to Canada.
Code Information
All Puritan Bennett 980 ventilators