HeartStart XL+ (2019-10-10)

Starting date:

October 10, 2019

Posting date:

October 25, 2019

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-71387

Last updated: 2019-10-25

• Reason
• Affected products

Affected Products

HeartStart XL+

Reason

Philips has identified that the HeartStart XL+ defibrillator/monitor (model number 861290) may fail to turn on or unexpectedly attempt to restart, rendering it unable to return to a ready for use state. Although the device indicates to the user that it is not ready for use, a failed restart may result in a delay in therapy if the defibrillator/monitor is needed for immediate use. This device behavior may be caused in some cases by a defect in the heartstart's memory management software and in other cases by a malfunction of the system on module (SOM) installed on the processor printed circuit assembly (PCA).

Affected products