FDA-Device2014-11-05Class I
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.
Nellcor Puritan Bennett Inc. (dba Covidien LP)
Hazard
A software issue may lead to ventilator inoperative situations.
Sold states
Worldwide Distribution -- USA, including the states of CA, CO, FL, GA, KY, MA, MN, NC, NY, OH, OK, PA, SC, TN, TX, UT, 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. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NICU) through Adult patient populations.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0112-2015Don't want to check this manually?
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