Nellcor Puritan Bennett Inc. (dba Covidien LP) recalls Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospita

Recalled November 5, 2014 · FDA recall Z-0112-2015 · Nellcor Puritan Bennett Inc. (dba Covidien LP)

Hazard

A software issue may lead to ventilator inoperative situations. · FDA Class I

Units

324 units

Sold at

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.

Description

A software issue may lead to ventilator inoperative situations.

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.

Manufacturer(s)

Nellcor Puritan Bennett Inc. (dba Covidien LP)

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