multidiagnost eleva fd 의 안전성 경고

Safety alert

2015-01-21

2015-01-21

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20150121a.html

Medical device safety alert: philips healthcare multidiagnost eleva fd medical device manufacturer, philips healthcare, has issued a field safety notice concerning multidiagnost eleva fd [product code: 708037]. in the md eleva system, software license keys are used to enable particular functionality. the manufacturer has discovered that in software release r6.1.1sp2 and r6.1.2 intermittently part of the software keys are not loaded: the license key for spectral filter the license key for full table tilt range if the license key for spectral filter is not loaded, then a higher than expected patient dose will occur in low dose mode for positioning of the patient, positioning of the x-ray beam, and/or in situations in which the x-ray image has lots of contrast. if the license key for full table tilt range is not loaded, then the table tilt range will be restricted. in such a case not all desired image projections are possible. the manufacturer will perform software upgrade for affected units before may 2015. according to the local supplier, the affected product is distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 21 january 2015.