FDA: Class I recall of GE Healthcare’s CARESCAPE R860 Ventilator

Editor's Note

The Food and Drug Administration (FDA) on June 28 identified the recall by GE Healthcare of its CARESCAPE R860 Ventilator as Class I, the most serious.

The recall was initiated because the ventilator backup batteries, including replacement backup batteries, may run out before they are expected to do so. If the battery fails while the ventilator is running on battery power only, ventilation could stop completely, causing the patient to lose oxygen and breathing support.

To date, there have been 1,553 complaints, no injuries, and no deaths associated with this problem.

Distribution dates were April 2, 2019, to April 18, 2022.