Physio-Control initiates select recall of Lifepak 20e defibs, monitors

Physio-Control is recalling select Lifepak 20e defibrillators and monitors over issues with power failures, according to a recall notice posted this month.

The voluntary recall affects Lifepak 20e units built between September 2016 and June 2017, the company said.

Physio-Control said it received reports from customers of power-related failures with the devices during initial deployment and during use within the first year of distribution. Failures included unexpected powering on and off, device lock-ups or failures to power on and off.

The company said that the reported issues have “the potential to result in a failure to deliver therapy to the patient and serious injury or death,” according to a letter it sent to customers with the devices.

Failures were deemed to be the result of manufacturing process residue located beneath a compartment mounted on the power printed circuit board assembly, Physio-Control said.

No adverse events related to the issue have been reported so far, the company added.

Physio-Control gave instructions to individuals with affected devices and instructed anyone experiencing the symptoms it described to contact it immediately to arrange for servicing.

Last October, Physio-Control launched a voluntary recall of pediatric defibrillation electrodes, made by Cardinal Health (NYSE:CAH), which are components in a number of the company’s Lifepak automated external defibrillators over issues with incorrect art that could lead to misuse.

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