GE Healthcare recalls replacement backup batteries for CARESCAPE R860 and Engström Carestations distributed after April 1, 2019, due to risk of ventilator shutdown without AC power.
Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply.
GE Healthcare is recalling replacement backup batteries for certain ventilators distributed starting April 1, 2019. This recall is needed because the batteries can cause the ventilator to shut down unexpectedly when not connected to AC power, which could be dangerous for patients.
The backup batteries may not hold enough power to keep the ventilator running when disconnected from AC power. This can cause the ventilator to shut down unexpectedly, potentially endangering patients who rely on it for breathing support.
Patients using ventilators with the recalled batteries, particularly those in hospitals or home care settings. Healthcare providers and caregivers are most at risk due to potential patient safety issues.
Check if your ventilator model is CARESCAPE R860, Engström Carestation, or Engström PRO Ventilator. The batteries were distributed starting April 1, 2019.
Verify the battery distribution date is on or after April 1, 2019.
Install the replacement field kit (PN: 1009-5682-000-S or PN: 5856787-S) as instructed by GE Healthcare.
The backup batteries may not hold enough power to keep the ventilator running when disconnected from AC power, causing premature shutdown.
CARESCAPE R860, Engström Carestation, and Engström PRO Ventilators with batteries distributed on or after April 1, 2019.
Contact GE Healthcare for the field replacement kit (PN: 1009-5682-000-S or PN: 5856787-S).
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1227-2022 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-1227-2022 from GE Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
