Allura Xper Radiographic Systems 의 안전성 경고

Safety alert

2014-07-09

2014-07-09

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20140709.html

Medical device safety alert: philips healthcare allura xper radiographic systems medical device manufacturer, philips healthcare, has issued a field safety notice concerning its allura xper radiographic systems. according to the manufacturer, as a result of a faulty automatic motion controller (amc), a problem in the power on self test (post) error handling was detected, which can result in a hazardous movement of the c-arc. this can only occur during startup of the system. when the problem in the post error handling during startup occurs, the c-arc might move unexpectedly. the image detector (which is connected to the same amc axis motion controller) may also move unexpectedly. the issue does not occur at every startup and is only present if a post-error handling is detected during the post phase. when the system is used to perform clinical interventional procedures, this might cause a harmful situation in which the patient or staff member is being touched by the moving part. the manufacturer advises that user must be cautious for any unexpected movement of the c-arc and image detector when a system start-up (cold restart) is required during a procedure to protect his own safety and the safety of the patient on the table. the manufacturer would provide updated software release r8.2.0.3 which addresses the positioning software to respond properly to this error. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 09 july 2014.