LifepaK CR Express (Semi-Automatic Operation)

Starting date:

October 4, 2016

Posting date:

November 3, 2016

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-60778

• Reason
• Affected products

Affected Products

Reason

Physio-Control has become aware of an issue whereby the LifepaK CR PLUS AED or LifepaK EXPRESS AED may fail to initiate voice prompts when the on/off button is pressed and the lid is opened due to an internal component (reed switch) that can intermittently become fixed in the closed position. Physio-Control has determined that there are presently 25,178 devices in the field, of which approximately 9,600 may have this faulty component. A defibrillator in this condition is not delivered and a patient is not resuscitated. All reports received from customers have been noted during initial set up and testing of the device.

Affected products