Alerta De Seguridad para brilliance ct series , ingenuity ct, ingenuity core, ingenuity core128, ingenuity flex, and mx8000 dual v. exp

Safety alert

2014-04-15

2014-04-15

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20140415.html

Medical device safety alert: philips brilliance ct series (6, 10, 16, 16 power, 40, 64, big bore, ict, ict sp), ingenuity ct, ingenuity core, ingenuity core128, ingenuity flex, and mx8000 dual v. exp medical device manufacturer, philips healthcare, has issued a medical device safety alert concerning its brilliance ct series (6, 10, 16, 16 power, 40, 64, big bore, ict, ict sp), ingenuity ct, ingenuity core, ingenuity core128, ingenuity flex, and mx8000 dual v. exp. thethe manufacturer has found that if the service latch is not properly secured during servicing of the device, the table top’s subframe will become free floating causing unintended, horizontal motion. the manufacturer has identified the following potential hazards: for the patient: there is a potential for disconnection or movement of invasive medical devices such as i.V.’s, tracheostomies, and surgical drains. for the operator/technician: there is a potential for pinch point on the subframe and also a potential for entrapment between the table and the gantry if the operator/technician stands between them to shift the patient forward. the manufacturer advises users to contact their field service engineers immediately if they experience a horizontal, free-floating couch motion. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 15 april 2014.