FDA issues Class I recall for Physio's Lifepak devices

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The FDA has issued a class I recall for Physio- Control's Lifepak 15 monitors/defibrillators after the company found that the devices have the potential to malfunction and power on and off unexpectedly.

According to the FDA, all Lifepak 15 devices manufactured between March 26, 2009, and Dec. 15, 2009, and distributed between March 27, 2009, and Dec. 15, 2009, are included in the recall.

While Redmond, Wash.-based Physio-Control, a division of Medtronic, said that no adverse events have been reported, during an internal analysis the company found that the devices may:

  • Power off and then on by itself;
  • Power off by itself requiring the device operator to turn it back on;
  • Power off and not be able to be turned back on; or
  • Stay powered on and not allow a technician to turn it off.

The company verified that the potential malfunctions are caused by the device “inadvertently contacting the power printed circuit board assembly."

According to the FDA, on March 4, Physio-Control sent a letter to device customers informing them that they should frequently test their device in accordance to the operating manual and keep the device in service.

The company said that it was scheduling service visits to investigate the devices within 60 days of the recall announcement.

Customers can check the affected Lifepak 15 serial numbers on the Physio-Control website (here). Additionally, the FDA asks device users to report adverse effects to its MedWatch Safety Information and Adverse Event Reporting Program.