Nellcor Puritan Bennett Inc. (dba Covidien LP) recalls Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.

Recalled December 17, 2014 · FDA recall Z-0180-2015 · Nellcor Puritan Bennett Inc. (dba Covidien LP)

Hazard

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. · FDA Class I

Units

324 units

Sold at

Worldwide Distribution-US (nationwide) including the states of CA, CO, FL, GA, KY, MA, MN, NC, NY, OH, OK, PA, SC, TN, TX, UT, and WI, and the countries of Canada, Mexico, Saudi Arabia, South Africa and United Arab Emirates.

Description

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.

Product

Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.

Manufacturer(s)

Nellcor Puritan Bennett Inc. (dba Covidien LP)

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →