Ingenia, Intera, Achieva and Multiva MR systems using R5.1.1 and R5.1.2 version of software 의 안전성 경고

Safety alert

2014-05-08

2014-05-08

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20140508a.html

Medical device safety alert: philips healthcare ingenia, intera, achieva and multiva mr systems using r5.1.1 and r5.1.2 version of software medical device manufacturer, philips healthcare, has issued a medical device safety alert concerning its ingenia, intera, achieva and multiva mr systems on r5.1.1 and r5.1.2 with the mobiview software option. according to the manufacturer, the cross reference lines of transversal images are displayed in an incorrect position on a fused image which has been generated through mobiview post processing. the cross reference lines are correctly displayed on the unfused stations. the problem can occur when the field of view of the clinical scan stations is below (more towards the feet) the light visor position. in such situation an error is made in calculating the position information. this causes incorrect positioning of cross-reference lines on fused sagittal images. the hazard is only expected in spine examinations, when using a whole spine survey, while the cervical spine is skipped for the clinical scan. there is a risk of misdiagnosis which could lead to incorrect therapy. the risk occurs when cross-reference lines on fused images are relied upon to determine location of transversal images. in mobiview applications other than spine, reference lines are not commonly used to identify or label anatomy because anatomical landmarks are used instead. the manufacturer advises affected users not to perform planning or review planning of transversal images on fused sagittal images which were generated through mobiview post-processing. instead, the planning of transversal scans should only be reviewed on the unfused stations. according to the local supplier, 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 08 may 2014.