Some Stryker Defibrillators Under Recall for ‘Freezing’ Issue

Physio-Control, part of Stryker, is performing a “field action” to correct an issue involving some of its LIFEPAK 15 monitors/defibrillators locking up after delivering a shock, an action the US Food and Drug Administration has deemed a class I recall.

“The resulting delay in delivering a shock could and has resulted in serious patient injury including death,” according to an FDA announcement.

Affecting 13,003 devices globally, including 8,164 in the United States, the problem has been linked to at least six patient deaths, Stryker said in an “Urgent Medical Device Safety Notice & Correction” letter sent to customers on February 1.

If a device freezes, the company said, it should either be reset or have its power sources removed and then reconnected to get it working again.

The problem affects monitors/defibrillators with printed circuit board assembly part number 3206834-011 or 3206834-012 that were distributed between March 21, 2013, and July 18, 2016. Stryker said affected devices will be serviced by the end of the year.