FDA Provides Update on GE Healthcare’s Recall of Its Carescape R860 Ventilators

The FDA has issued an update on GE Healthcare’s April 18 recall of backup batteries for its Carescape R860 ventilators, deeming it a Class 1 recall because of the risk of serious injury or death.

The reason for the recall is that early failure of the backup batteries may cause unexpected ventilator shutdown.

If the ventilator is running on battery power only when the battery fails, ventilation could stop completely, preventing the patient from receiving oxygen and breathing support, the agency said. The 4,222 affected products were distributed from April 2, 2019 to April 18.

There have been 1,553 complaints but no injuries or deaths linked to the battery failures so far, the FDA said.