Multiple Allura systems(Fluoroscopic x-ray systems) 의 리콜

Recall

RC-2015-RN-00604-1

Class I

2015-07-02

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00604-1

Customer reported an issue with a failing monitor ceiling suspension (mcs) actuator of an allura xper system. the actuator assembly had become detached and the monitor carriage with a flexvision monitor dropped to its lowest position. the monitor ceiling suspension is designed to allow flexible positioning near the patient table when in use, and away from the patient when not in use (park position).When the monitor ceiling suspension falls to its lowest position there is a possibility it might collide with patient or personnel in the room. there is also the possibility that the monitor ceiling suspension collides with other equipment in close proximity of the mcs.

Philips will check if the actuator serial number is on the affected product list. If the actuator is on the affected product list the immediate containment action is to secure the MCS with straps to prevent the monitors to fall down in case the actuator fails. Actuators on the affected products will be replaced by Philips. In order to avoid any risk for patients, users or bystanders Philips recommend the following until the containment action FCO has been implemented: - Do not position or move the Monitor Ceiling Suspension above the patient. - Do not allow staff to stand under or close to the Monitor Ceiling Suspension. Additionally avoid any unnecessary movement of the Monitor Ceiling Suspension and inform all possible System users. This action has been closed-out on 15/08/2016.