Heartstart MRx Defibrillator/Monitor (2014-11-17)

Starting date:

November 17, 2014

Posting date:

December 4, 2014

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-42719

• 
  Reason
• 
  Affected products

Recalled Products

Heartstart MRx Defibrillator/Monitor

Reason

Philips has become aware that the Heartstart MRx defibrillator/monitor may contain incorrect internal software settings, causing the following two (2) issues:  1. The device will perform the weekly automated tests hourly, which could cause the therapy capacitors to degrade sooner than intended.  2. While connected to AC or DC power and with no battery installed or the battery installed has a charge level of less than 10%, the ready for use (RFU) indicator will not provide the expected low battery indication (flashing red x with audible chirp). Instead, the RFU will show a flashing black hourglass, indicating that sufficient battery power is available for device operation.  Note: once the device is disconnected from AC or DC power, the RFU indicator provides the appropriate low battery indications. In addition, all other battery charge indicators continue to operate normally, including the onscreen battery fuel gauges, low battery messages, and low battery alarms. The led charge level indicators on the batteries themselves also operate normally.

Affected products