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# GE Carescape Ventilator Recall is Class 1
- URL: https://www.fdaweb.com/ge-carescape-ventilator-recall-is-class-1/
- Published: 2022-06-28T12:00:00.000Z
- Updated: 2026-09-14T17:50:26.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5152185

FDA says the GE Healthcare 4/18 recall of its Carescape R 860 ventilator backup batteries and replacement backup batteries manufactured on or after 4/1/19 is Class 1\. An agency announcement [says](https://www.fda.gov/medical-devices/medical-device-recalls/ge-healthcare-recalls-carescape-r860-ventilator-due-early-failure-backup-batteries-may-cause/?utm%5Fmedium=email&utm%5Fsource=govdelivery) GE recalled 4,222 units distributed between 4/2/19 and 4/18/22 because the batteries may run out before they are expected to do so. “If the ventilator is running on battery power only when the battery fails,” the notice says, “ventilation could stop completely, preventing the patient from receiving oxygen and breathing support.”

The agency says there have been 1,553 complaints, one injury, and no deaths associated with using the device.