Companion External Battery 의 안전성 경고

Safety alert

2013-01-14

2013-01-10

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20130114.html

Medical device safety alert: syncardia companion external battery the food and drugs administration (fda), united states posted a medical device safety alert concerning companion external battery, part number: 293001-001, manufactured by syncardia systems, inc. according to the fda, the companion external battery is a component of the companion 2 driver system and the companion driver system. both driver systems, with the temporary total artificial heart are indicated for use as a bridge to transplantation in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure. the manufacturer is recalling the companion external batteries used with the companion 2 driver system because they may potentially be at risk of thermal events and/or other physical damage such as melting, charring and/or burning. for details, please visit the following fda website: http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-product-tabs.Cfm? action=select&recall_number=z-0620-2013&w=01092013&lang=eng if you are in possession of the product, please contact your supplier for necessary actions. posted on 10 january 2013.