Puritan Bennett 980 Ventilator System — Class II medical device recall Z-1058-2015
Terminated recall by Covidien LP (formerly Nellcor Puritan Bennett Inc.), reported 2015-02-11, distributed nationwide. Covidien is issuing a voluntary field action for all Puritan Bennett 980 ventilators due to occasional GUI tra
| Recall number | Z-1058-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien LP (formerly Nellcor Puritan Bennett Inc.), Boulder, CO, United States |
| Recall initiated | 2015-01-12 |
| Classified | 2015-02-05 |
| Reported by FDA | 2015-02-11 |
| Terminated | 2016-01-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 418 units |
| Model numbers | PB980 |
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.
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.