Events

Recall of GE LOGIQ S8 and LOQIQ S7 Ultrasound

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by GE Ultrasound Korea 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
    14572
  • Event Initiated Date
    2013-04-30
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
  • Reason
    Manufacturer has recently become aware of a potential safety issue due to the s4-10-d ultrasound probe used in conjunction with the logiq s8 and logiq s7 ultrasound systems. it was also discovered that this issue also leads to a specification issue of the acoustic output of this probe, there is a potential for a skin burn when the flow model in the cardiac application is activated with the s4-10-d ultrasound probe.
  • Action
    Software to be upgraded

Device

GE LOGIQ S8 and LOQIQ S7 Ultrasound
  • Model / Serial
    Model: , Affected: with software revisions R.1.1.1 , R1.5.1 and R1.0.1, R1.0.2 and R1.0.3
  • Manufacturer
    GE Ultrasound Korea Ltd

Manufacturer

GE Ultrasound Korea Ltd