TBS iNsight 의 안전성 경고

Safety alert

2016-11-09

2016-11-09

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20161110.html

Medical device safety alert: medimaps tbs insight medical device manufacturer, medimaps, has issued a medical device safety alert concerning its tbs insight [software version v.3.0.1]. the manufacturer identified a bug in v.3.0.1 when calculating the fracture-risk-assessment-tool (frax) adjusted for trabecular bone score (tbs). according to the manufacturer, the new version of tbs insight v.3.0.2 is available and will fix the following bugs: frax adjusted for tbs: tbs insight v.3.0.2 provides correct calculation of the frax adjusted for tbs. as a reminder, tbs insight 3.0.1 generated erroneous frax adjusted for tbs values or did not generate tbs report in the following case of vertebrae exclusions: if (l1 & l3) or (l2 & l3) are excluded from the bone mineral density (bmd) analysis, if l1-l4 is not entirely scanned, if only l2 or only l3 are excluded from the bmd analysis, when the “always use l1-l4” or “always use l2-l4” option is activated in tbs insight apex archiving: the tbs pop-up window does not prompt during scans archiving process whatever the type of configuration used for scan detection (dxa database monitoring or folder section]. no need to close scan detector anymore. wording improved in different languages on tbs report. the affected customers are advised that an upgrade to v.3.0.2 has to be done as well as an impact assessment. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 9 november 2016.