LOGIQ S7 and S8 의 안전성 경고

Safety alert

2013-04-18

2013-04-18

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20130418a.html

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.