brilliance ct 64, ingenuity core and ingenuity core128 systems 의 안전성 경고

Safety alert

2013-05-03

2013-05-03

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20130503.html

Medical device safety alert: philips brilliance ct 64, ingenuity core and ingenuity core128 systems medical device manufacturer, philips healthcare issued a medical device safety alert concerning all brilliance ct 64, ingenuity core and ingenuity core128 systems using software versions 2.6.1 or 3.5.4. philips healthcare received reports from the field that certain brilliance ct 64, ingenuity core and ingenuity core128 systems running software versions 2.6.1 or 3.5.4 exhibited intermittent swirl-like ring artifacts that may appear on reconstructed images, which may impair the diagnostic quality of affected images. philips healthcare states that there are no proactive actions for the user. clinical judgment should be used by the customer or user to determine if the images contained in the dataset without artifacts contain enough information to make a diagnosis. if these images are sufficient, no further action is required. if the images are not sufficient, a rescan of the patient is required. philips healthcare is implementing software update versions 2.6.2 or 3.5.5 to correct the above-described issue. according to the local supplier, philips electronics hong kong ltd, 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 3 may 2013.