FDA Device recall Z-2329-2015
Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality enabled) and Neonatal Models
- FDA Device
- Class I
- terminated
- Published 2015-08-26
On 2015-08-26 the FDA classified a Class I recall of Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality enabled) and Neonatal Models by Covidien Formerly Nellcor Puritan Bennett, citing reports in which tidal volumes reaching patients were lower than set tidal volumes in neonatal Volume Control Plus (VC+) Mode with active humidification. This situation may potent….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2329-2015 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2015-07-16 |
| Published | 2015-08-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Covidien Formerly Nellcor Puritan Bennett |
| Distribution | US |
Product
Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality enabled) and Neonatal Models. 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).
Reason
Reports in which tidal volumes reaching patients were lower than set tidal volumes in neonatal Volume Control Plus (VC+) Mode with active humidification. This situation may potentially lead to respiratory compromise if not recognized.
Identifiers
| code_info | PB980 Ventilator (980xxxxxxxx): 980U1ENDIUU, 980U1ENDIUUS, 980U3ENDIUU, 980U3ENDIUUS, 980N1ENDIUU, 980N1ENDIUUS, 980N3ENDIUU, 980N3ENDIUUS |
|---|
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-2329-2015%22
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