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