Stellaris PC Vision Enhancement System with Integrated Laser 의 안전성 경고

Safety alert

2014-11-13

2014-11-13

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20141113.html

Medical device safety alert: bausch & lomb stellaris pc vision enhancement system with integrated laser medical device manufacturer, bausch & lomb, inc., has initiated a voluntary product recall concerning the stellaris pc vision enhancement system with integrated laser. the affected products are as follows: stellaris pc w/ laser: part number bl14304. stellaris pc w/ laser upgrade: part numbers bl1433 (stellaris pc w v3 software) with bl2272 (laser upgrade kit) and bl14334 (stellaris pc w v4 software) with bl2272 (laser upgrade kit). the manufacturer has identified a software anomaly where it can occur that when in surgery, if the surgeon requests a laser sub-mode change (i.E. from endo mode to endo continuous mode) and the system is in “standby”, the system will automatically transition to “ready” to fire state. this defeats one of the several safety mechanisms in the device to prevent inadvertent firing of the laser. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 13 november 2014.