Events

Recall of HEARTSTART XL+

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PHILIPS ELECTRONICS LTD..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    59988
  • Event Risk Class
    II
  • Event Initiated Date
    2015-06-30
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 recall data from the U.S. and Canada.
  • Extra notes in the data
  • 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: a. the xl+ may have been manufactured with a speaker that may fail. b. the battery may not seat properly causing the xl+ to shut down unexpectedly or remain powered on and not acknowledge or charge the battery. c. the xl+ exceeds the allowable radiated emissions level for class b cispr11. d. the xl+ ecg signal from leads could be lost and unrecoverable. e. the xl+ spo2 signal may lose communication and cause the device to reboot. f. the xl+ battery detection system may be disrupted and cause a false low battery alarm.

Device

HEARTSTART XL+
  • Model / Serial
    Model Catalog: 861290 (Lot serial: >10 contact mfg.)
  • Product Description
    HEARTSTART XL+
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

PHILIPS ELECTRONICS LTD.
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    HC