GE Healthcare, LLC recalls Replacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, Engstr¿om Carestation and Engst

Recalled June 15, 2022 · FDA recall Z-1227-2022 · GE Healthcare

Hazard

Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply. · FDA Class I

Units

88,379 batteries

Sold at

Worldwide Distribution: US (nationwide) to AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and OUS (internationally) to Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Columbia, Cote D'Ivoire, Mexico, Uruguay, United Kingdom, United Arab Emirates, Turkey, Thailand, Tanzania, Sweden, Spain, Singapore, Saudi Arabia, Russia, Romania, Portugal, Poland, Philippines, Panama, Omar, Norway, Nigeria, Nicaragua, New Zealand, Netherlands, Malaysia, Latvia, Kuwait, Korea, Kenya, Kazakhstan, Japan, Italy, Ireland, Indonesia, India, Hungary, Germany, France, Finland, Estonia, Egypt, Ecuador, Denmark, Czech Republic.

Description

Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply.

Product

Replacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, Engstr¿om Carestation and Engstr¿om PRO Ventilators.

Manufacturer(s)

GE Healthcare, LLC

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