Philips HeartStart XL+ Defibrillator/Monitor 의 리콜

Recall

RC-2015-RN-00588-1

Class I

2015-07-02

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00588-1

The following xl+ software and hardware issues have been identified:software:the xl+ may fail to complete the power on sequence and continuously reboot. the xl+ may either fail to power up or may shut down unexpectedly. the xl+ may have a software version that did not reset a fail-safe monitoring component which could delay of therapy or pacing interruption. the xl+ may fail to generate verbal prompts in aed mode. hardware:the xl+ may have been manufactured with a speaker that may fail. the battery may not seat properly causing the xl+ to shut down unexpectedly or remain powered on and not acknowledge or charge the battery. the xl+ exceeds the allowable radiated emissions level for class b cispr11. the xl+ ecg signal from leads could be lost and unrecoverable. the xl+ spo2 signal may lose communication and cause the device to reboot. the xl+ battery detection system may be disrupted and cause a false low battery alarm.

A Philips Healthcare representative will contact customers with affected devices to arrange for installation of the software and hardware upgrades. In the interim, users can continue to use XL+ prior to receiving the software and hardware upgrades; however they should identify a readily available backup defibrillator to use in the event the affected HeartStart XL+ exhibits any of these issues.