Important Safety Alerts

Medical device manufacturer, Philips Healthcare issued a medical device safety alert concerning Philips HeartStart XL+ Defibrillator/Monitor (model number 861290). The affected devices were manufactured from October 2011 to January 2013, and shipped worldwide with serial numbers within the ranges below:

• USO1100100 – USO1100372
• US61201722 – US61201924
• USN1100376 – USN1100960
• US71201925 – US71202048
• USD1100961 – USD1101095
• US81202049 – US81202168
• US11201096 – US11201186
• US91202169 – US91202514
• US21201187 – US21201239
• USO1202515 – USO1202990
• US31201240 – US31201537
• USN1202991 – USN1203537
• US41201538 – US41201585
• USD1203538 – USD1203968
• US51201586 – US51201721
• US11303969 – US11303972

According to Philips, the Philips HeartStart XL+ Defibrillator/Monitor may fail to power on in clinical mode and instead, power on in service mode displaying an "Equipment Disabled: Therapy" prompt, requiring the user to enter a password and perform an Operational Check to clear the condition. As the device will not return to clinical mode until an Operational Check is performed, a delay in therapy may occur.

Philips revealed that a software upgrade would be arranged to address the problem. Meanwhile, customers are advised to continue to use the device by following any one of these three conditions (1, 2, or 3):-

1. When turning the Philips HeartStart XL+ Defibrillator/Monitor on, wait for a clinical mode screen to appear before removing AC power
2. Remove AC power before turning the Philips HeartStart XL+ on
3. Do not disconnect the HeartStart XL+ Defibrillator/Monitor from AC power when in clinical use

According to the local supplier, Philips Electronics Hong Kong Ltd, the affected products have been distributed in Hong Kong.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 21 February 2013