GE Healthcare, LLC recalls Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116)

Recalled June 15, 2022 · FDA recall Z-1226-2022 · 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

34,940 ventilators

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

Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)

Manufacturer(s)

GE Healthcare, LLC

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