Events

Recall of SLE 5000 Ventilator

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by AHC Solutions Pty 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
    RC-2013-RN-00855-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-08-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00855-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    The manufacturer has identified a potential risk associated with the fp110-410 psu (power supply unit). their internal monitoring and investigations have identified a suspect batch of electrolytic capacitors used on the main pcb (printed circuit board) of the 410 power supply unit. the affected capacitors may exhibit a swelling that if not replaced, may in time cause the ventilator to shut down during normal operation. please note that should the ventilator shut down, a total power fail alarm will sound.
  • Action
    AHC Solutions is advising users to identify ventilators with serial numbers below 53164 and, using the instructions provided, identify ventilators with Power Supply Units with serial numbers between 163746 to 167558 for replacement.

Device

SLE 5000 Ventilator
  • Model / Serial
    SLE 5000 VentilatorVentilator model SLE 5000: Serial numbers below 53164Power supply unit model FP110-410: Serial numbers 163746 to 167558 inclusiveARTG Number: 114000
  • Manufacturer
    AHC Solutions Pty Ltd

Manufacturer

AHC Solutions Pty Ltd