Covidien LLC recalls Rechargeable Li-ion battery used with Puritan Bennett TM 980 Series Ventilator System including Pediatric-Adult Ventilat

Recalled April 4, 2018 · FDA recall Z-1208-2018 · Covidien

Hazard

Rechargeable lithium-ion batteries with incorrect firmware that are used in certain Puritan Bennett 980 ventilators may not fully charge after installation. · FDA Class II

Units

15,885

Sold at

Worldwide Distribution - USA (nationwide) Distribution to the states of : AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY, and the District of Columbia. and to the countries of : Argentina, Chile, Mexico, Panama, Canada, Australia, New Zealand, Austria, Bahrain, Belgium, Bulgaria, Croatia, Czech Republic, Egypt, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Jordan, Kuwait, Latvia, Lebanon, Lithuania, Morocco, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, Israel, Netherlands, Tunisia, Brunei, Indonesia, Malaysia, Myanmar, Philippines, Singapore, Thailand, and Vietnam

Description

Rechargeable lithium-ion batteries with incorrect firmware that are used in certain Puritan Bennett 980 ventilators may not fully charge after installation.

Product

Rechargeable Li-ion battery used with Puritan Bennett TM 980 Series Ventilator System including Pediatric-Adult Ventilator, Neonatal Ventilator, Universal Ventilator; Battery Product Number: 10086042; UDI: 20884521700861 The rechargeable lithium-ion batteries are intended to provide a backup power source to the ventilator in case AC power is lost.

Manufacturer(s)

Covidien LLC

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