Events

Safety Alert for HeartStart XL+ Defibrillator/Monitor

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Philips Medical Systems.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2013-02-21
  • Event Date Posted
    2013-02-21
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130221b.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: philips heartstart xl+ defibrillator/monitor 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.

Device

HeartStart XL+ Defibrillator/Monitor
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: [6 Jul 2015] Philips Medical Systems HeartStart XL+ Defibrillator/Monitor
  • Manufacturer
    Philips Medical Systems

Manufacturer

Philips Medical Systems
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    DH