FDA-Device2014-12-17Class I
Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.
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.
Sold states
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.
Affected count
324 units
Manufactured in
6135 Gunbarrel Ave, N/A, Boulder, CO, United States
Products
Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0180-2015Don't want to check this manually?
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