Stereo Biopsy Device used with Mammomat Inspiration Mammography System 의 안전성 경고

Safety alert

2014-09-29

2014-09-29

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20140929c.html

Medical device safety alert: siemens stereo biopsy device used with mammomat inspiration mammography system the australia therapeutic goods administration (tga), has issued a medical device safety alert concerning stereo biopsy device used with mammomat inspiration mammography system [material number: 10140000], manufactured by siemens ltd. the stereo biopsy devices for mammomat inspiration mammography systems might have integrated a safety switch which causes a failure of the functionality. the pin implemented in the safety switch may not put enough pressure on the safety circuit to prohibit movement. the needle positioning device may move even with the safety switch being set sideward. if this occurs with the needle being already inserted, it could lead to an unintentional patient injury. affected users are advised that in case the needle holder moves unintentionally to press the emergency stop. the manufacturer is recommending inspection of the safety switch before every biopsy until the problem is solved. furthermore, it is preparing a modification of the safety switch. for details, please refer to the following tga website:http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2014-rn-01040-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 29 sep 2014.