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Products, Regulatory

GE Healthcare Recalls Carescape R860 Ventilator Due To Early Failure Of Backup Batteries That May Cause Unexpected Ventilator Shut Down

Published: 06/28/2022 15:38 GMT
General Electric Co. (GE) - GE Healthcare Recalls Carescape R860 Ventilator Due to Early Failure of Backup Batteries That May Cause Unexpected Ventilator Shut Down.
FDA- FDA Has Identified Recall of Carescape R860 Ventilator As a Class I Recall.
FDA- There Have Been 1,553 Complaints, One Injury, and No Deaths Associated With the Use of Carescape R860 Ventilator Device.
FDA- GE Healthcare is Recalling Carescape R860 Ventilator Backup Batteries, Including Replacement Backup Batteries, Manufactured On,after April 1, 2019.
FDA- 4,222 Carescape R860 Ventilator Devices Recalled in the U.S.