Replacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, Engstr¿om Carestation and Engstr¿om PRO Ventilators.
Reported: June 15, 2022 Initiated: April 18, 2022 #Z-1227-2022
Product Description
Replacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, Engstr¿om Carestation and Engstr¿om PRO Ventilators.
Reason for Recall
Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply.
Details
- Recalling Firm
- GE Healthcare, LLC
- Units Affected
- 88,379 batteries
- Distribution
- 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.
- Location
- Waukesha, WI
Frequently Asked Questions
What product was recalled? ▼
Replacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, Engstr¿om Carestation and Engstr¿om PRO Ventilators.. Recalled by GE Healthcare, LLC. Units affected: 88,379 batteries.
Why was this product recalled? ▼
Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 15, 2022. Severity: Critical. Recall number: Z-1227-2022.
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