Events

Safety Alert for LOGIQ S7 and S8

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

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
    2013-04-18
  • Event Date Posted
    2013-04-18
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130418a.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: ge healthcare logiq s7 and s8 the united states food and drug administration (fda) has issued a medical device safety alert concerning logiq s8 (with software revisions r1.1.1 and r1.5.1) and s7 (with software revisions r1.0.1, r1.0.2 and r1.0.3) diagnostic ultrasound system with the s4-10-d ultrasound probe manufactured by ge healthcare, llc. according to the safety alert, ge healthcare has 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 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. for details, please visit the following fda website: http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-event-detail.Cfm? action=detail&id=64725&w=04172013&lang=eng if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 18 april 2013.

Device

LOGIQ S7 and S8
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: GE Healthcare LOGIQ S7 and S8
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare