intellispace portal dx/hx/ex, intellispace portal ix, and intellispace portal lx spect 의 안전성 경고

Safety alert

2014-08-07

2014-08-07

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20140807a.html

Medical device safety alert: philips healthcare intellispace portal dx/hx/ex, intellispace portal ix, and intellispace portal lx spect medical device manufacturer, philips healthcare, has issued a field safety notice (fsn) concerning its intellispace portal dx/hx/ex, intellispace portal ix, and intellispace portal lx spect (software versions: 5 and 6). the affected software versions include 5.0.0, 5.0.1, 5.0.2, 6.0.0, 6.0.1 and 6.0.2. there are four problems mentioned in the fsn: problem 1: when reopening a bookmark generated from processing a muga (multi-gated acquisition) scan within the nm cardiac application, the ejection fraction (ef) displayed should be the same as the ef originally displayed when the bookmark was first created. in some instances, the ef may be different. there is a risk of the patient receiving an incorrect treatment plan. problem 2: when processing using one of the following nm clinical applications: auto quant, emory cardiac toolbox, corridor4dm, or neuroq, the patient study presented to the reviewing physician within the application may be for a different patient than the one selected from the patient directory. there is risk of the patient receiving an incorrect treatment plan due to misdiagnosis. problem 3: while using the nm viewer application, an arrow annotation added to a display moves away from its original position if the viewer is subsequently maximized or if the image within the viewer is subsequently zoomed in or out. incorrect area indicator annotation results in an erroneous final nuclear medicine report, which may cause subsequent mistreatment. problem 4: while displaying pet images within ct viewer, the suv results displayed may be calculated with an suv method different from the one specified in system preferences. there is a risk of misdiagnosis if suv calculation method applied is not the method selected by the user. the manufacturer will install updated software versions 5.0.2.3 and 6.0.2.3 to correct the issue. service engineer will contact the customer for implementation of the software update on the affected systems. until the site’s software is updated, the manufacturer advises users to perform the workarounds mentioned in the fsn based upon the above problem descriptions. 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 7 aug 2014.