Asahi Kasei (TYO:3407) subsidiary Zoll Medical this month issued a field advisory for its AED Pro automated external defibrillator after receiving a report that a unit failed during use.
Chelmsford, Mass.-based Zoll said its investigation traced the problem to an “isolation breakdown” on an area of the AED Pro’s internal circuit board.
“If the isolation breakdown occurs during a shock attempt, the device will issue the “Unit Failed” message and prevent delivery of the energy to the patient,” Zoll said in the June 12 field advisory.
Zoll said the potential fault, which requires a hardware update to correct, involves AED Pros shipped between March 2018 and this month.
“We have notified the FDA and other regulatory agencies of this corrective action and expect it to be classified as a recall,” the company said.
