Heartstart MRX Defibrillator/Monitor (2014-02-18)

Starting date:

February 18, 2014

Posting date:

March 21, 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-38527

• 
  Reason
• 
  Affected products

Recalled Products

Heartstart MRX Defibrillator/Monitor

Reason

Philips has become aware that a component of the MRX processor board may be susceptible to damage from electrostatic discharge (ESD). Damage to these components can disrupt ECG and SPO2 functionality leading to an inability to perform:

• demand mode pacing
• 12 lead ECG acquisition and analysis
• ECG monitoring via leads
• pulse oximetry (SPO2)

The presence of this condition will be displayed on the ready for use (RFU) indicator as a solid red x with periodic audio chirp.  Defibrillation, fixed mode pacing, ECG monitoring via pads/paddles, and other monitoring functions are not impacted by this issue.

Affected products