Recall Z-0112-2015— Nellcor Puritan Bennett Inc. (dba Covidien LP)
Class I · Terminated
Class I FDA medical device recall by Nellcor Puritan Bennett Inc. (dba Covidien LP), initiated 2014-10-01, terminated 2016-05-02. It names one FDA 510(k) clearance: K131252. Product: Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NICU) through Adult patient populations.. Reason: A software issue may lead to ventilator inoperative situations..
- Recalling firm
- Nellcor Puritan Bennett Inc. (dba Covidien LP)
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2014-10-01
- Terminated
- 2016-05-02
- Firm location
- Boulder, CO, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NICU) through Adult patient populations.
Reason for recall
A software issue may lead to ventilator inoperative situations.
Data sourced from openFDA. This site is unofficial and independent of the FDA.