ingenia, intera, achieva and achieva dstream mr systems 의 안전성 경고

Safety alert

2014-08-12

2014-08-12

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20140812b.html

Medical device safety alert: philips healthcare ingenia, intera, achieva and achieva dstream mr systems medical device manufacturer, philips healthcare, has issued a field safety notice (fsn) concerning its ingenia, intera, achieva and achieva dstream mr systems on r5.1 .7 and r5.1 .8 with the mobi view software option. according to the fsn, when scrolling through mobiview fused sagittal/coronal images, the actual display order of the images on the screen is opposite to previous releases. this behaviour is seen on the mr console as well as on workstations and the picture archiving and communication system (pacs). the slice numbering of fused sagittal and coronal images is reversed compared to the unfused sagittal and coronal images. as a result, source image slice 1 becomes fused image slice 9 in sagittal/coronal direction, and vice versa. the slice numbering is correct in the transverse direction. the manufacturer advises users of the followings: to avoid possible confusion, the unfused images, transverse images and anatomical landmarks should be included in reading the examination. both unfused and fused images should be exported to the pacs and workstations. furthermore, the manufacturer plans to create a field change order to install updated software in a service pack that makes the slice numbering consistent for fused and unfused images. 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 12 aug 2014.