HEARTSTART XL+ (2015-06-25)

Starting date:

June 25, 2015

Posting date:

July 21, 2015

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-54310

• Reason
• Affected products

Affected Products

A.HEARTSTART XL+

Reason

Through internal testing and customer complaint investigations, the following XL+ software and hardware issues have been identified:

Software:

1. The XL+ may fail to complete the power on sequence and continuously reboot.
2. The XL+ may either fail to power up or may shut down unexpectedly.
3. The XL+ may have a software version that did not reset a fail-safe monitoring component which could delay of therapy or pacing interruption.
4. The XL+ may fail to generate verbal prompts in AED mode.

Hardware:

1. The XL+ may have been manufactured with a speaker that may fail.
2. The battery may not seat properly causing the XL+ to shut down unexpectedly or remain powered on and not acknowledge or charge the battery.
3. The XL+ exceeds the allowable radiated emissions level for class B Cispr11.
4. The XL+ ECG signal from leads could be lost and unrecoverable.
5. The XL+ Spo2 signal may lose communication and cause the device to reboot.
6. The XL+ battery detection system may be disrupted and cause a false low battery alarm.

Affected products