Philips has issued two separate recalls for its HeartStart XL+ defibrillator/monitor which may delay therapy and endanger patients.
One recall relates to the device’s potential to fail to start or to unexpectedly try to restart and affects only devices sold outside the U.S. and Canada. It is associated with 588 customer complaints since 2011 and two patient deaths.
In some cases, the problem may stem from a defect in the HeartStart’s memory management software. In others, the cause may be a malfunction of the System On Module (SOM) installed on the processor printed circuit assembly (PCA). Philips said it will perform a system software upgrade and replace the processor PCA that contains the faulty SOM module.
The other is a global recall of the same model made before 2017, whose rotary therapy selector switch may fail. This failure may potentially cause the device to not start, to fail to perform the selected function or to deliver the wrong level of shock to the patient. No adverse events regarding this second recall have been reported, and those that do not exhibit these issues may remain in service, according to Philips.
The recalled devices, all carrying model number 861290, were discontinued in December 2017, the company noted.
“Philips is committed to the highest standards of quality and reliability for our defibrillator products, and we take this matter very seriously,” the company said in an email to MassDevice. “We are working closely with our customers to resolve this matter at the earliest opportunity.”