FDA Device recall Z-1058-2015
Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxxx), The Puritan BennettTM 980 Ventilator System is designed fo…
- FDA Device
- Class II
- terminated
- Published 2015-02-11
On 2015-02-11 the FDA classified a Class II recall of Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxxx), The Puritan BennettTM 980 Ventilator System is designed fo… by Covidien Formerly Nellcor Puritan Bennett, citing covidien is issuing a voluntary field action for all Puritan Bennett 980 ventilators due to occasional GUI transient resets that last approximately 30 seconds.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1058-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-01-12 |
| Published | 2015-02-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Covidien Formerly Nellcor Puritan Bennett |
| Distribution | US |
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
Covidien is issuing a voluntary field action for all Puritan Bennett 980 ventilators due to occasional GUI transient resets that last approximately 30 seconds.
Identifiers
| code_info | All Puritan Bennett 980 ventilators |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1058-2015%22
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