# FDA recall Z-1227-2022

> **GE Healthcare, LLC** · Class I · device recall initiated 2022-04-18.

## Product

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.

## 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.

## Key facts

- **Recall number:** Z-1227-2022
- **Recalling firm:** GE Healthcare, LLC
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-04-18
- **Report date:** 2022-06-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waukesha, WI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1227-2022

## Citation

> AI Analytics. FDA recall Z-1227-2022. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-1227-2022. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*