Recall Z-0180-2015— 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 2016-07-01. It names one FDA 510(k) clearance: K131252. Product: Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.. Reason: Covidien is recalling certain Puritan Bennett 980 Ventilator Systems due to a blacklight inverter PCBA where a capacitor component can fail, causing a dim but functional screen and thermal odor..
- Recalling firm
- Nellcor Puritan Bennett Inc. (dba Covidien LP)
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2014-10-01
- Terminated
- 2016-07-01
- 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, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.
Reason for recall
Covidien is recalling certain Puritan Bennett 980 Ventilator Systems due to a blacklight inverter PCBA where a capacitor component can fail, causing a dim but functional screen and thermal odor.
Data sourced from openFDA. This site is unofficial and independent of the FDA.