Alerta De Seguridad para EasyDiagnost (70642, 70643, 706030, 706031, and 706032)

Safety alert

2012-08-06

2012-08-06

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20120806a.html

Medical device safety alert: philips easydiagnost medical device manufacturer, philips healthcare, has initiated a field safety corrective action for philips easydiagnost (70642, 70643, 706030, 706031, and 706032). only units that have had the inclination switch replaced during service are affected. according to the manufacturer, an inclination switch in the stand may have been mounted incorrectly during system service. there is a potential that a significant compression force could be exerted on a patient if, due to a combination of software and hardware errors, the inclination switch is not activated and the tilting movement is not immediately stopped. this severe squeezing has the potential to result in serious harm or injury. however, there is a very low probability that this combination of errors would occur. the manufacturer advised users to refer to the ifu for actions taken in preventing unintended compression by inserting the "compression stop" in the highest position. a field service engineer will be dispatched to verify if a switch was installed properly, and in the event it was not installed properly s/he will reinstall it properly. according to the local supplier, the affected devices were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 6 august 2012.