brilliance 64, brilliance ict, brilliance ict sp, ingenuity core, ingenuity core128, ingenuity ct, brilliance ct bigbore and iqon spectral ct 의 안전성 경고

Safety alert

2018-07-18

2018-07-24

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20180725.html

Medical device safety alert: brilliance 64, brilliance ict, brilliance ict sp, ingenuity core, ingenuity core128, ingenuity ct, brilliance ct bigbore and iqon spectral ct medical device manufacturer, philips electronics hong kong ltd., has issued a medical device safety alert concerning its products as follow: a) brilliance 64, brilliance ict, brilliance ict sp, ingenuity core, ingenuity core128, and ingenuity ct with software version 4.1.6; b) brilliance ct bigbore and with software version 4.2.0; c) iqon spectral ct with software versions 4.7.0 and 4.7.2. the manufacturer reported that scanners running software versions 4.1.6 (brilliance ict and ingenuity ct), 4.2 (brilliance bigbore), and 4.7.0 and 4.7.2 (iqon) with the heartbeat cs pro option provide confusing information in the “impressions” section of the heartbeat calcium score report. according to the manufacturer, the generated report provides multiple analyses of the amount of plaque detected, as if they all apply to the patient at the same time. the user cannot modify the content of the template to create user-tailored formats nor can they edit the reports generated from the template to remove/correct information. in addition, the report includes blank table cells that the customer is unable to edit using preferences. the manufacturer is aware of the users’ concerns with the confusing content and inability to edit the reports and is working to address them appropriately: fco72800660 has been released to update the brilliance ct bigbore to software version 4.2.1 which resolves this issue; fco72800689 has been released to update the iqon to heartbeat release version 4.7.5 which resolves this issue; fco72800675 has been released to update the brilliance 64 and ingenuity ct/core/core128 to heartbeat release version 4.1.7 which resolves this issue; fco72800678 has been released to update the brilliance ict and ict sp to heartbeat release version 4.1.7 which resolves this issue. for users, it is reminded that the "impressions" section of the report is not intended for diagnostic use. when determining treatment, the user should focus on the total calcium score shown in the "findings" section, the coronary artery score(s), and/or the "age and gender" graph as identified in the instructions for use (ifu). for further information on the calcium scoring application, users can refer to the following applicable ifu: 459801063511_d–ict family - instruction for use (ifu)–section 10–using analysis packages–heartbeat calcium scoring (hbcs); 459801063521_d–ingenuity family - instruction for use (ifu)–section 10–using analysis packages– heartbeat calcium scoring (hbcs); 459801063531_d–brilliance ct 64-channel - instruction for use (ifu)–section 10–using analysis packages – heartbeat calcium scoring (hbcs); 459800917202_c–iqon spectral ct - instruction for use (ifu)–section 10–using analysis packages– heartbeat calcium scoring (hbcs); 459800863011_d–brilliance ct big bore - instruction for use (ifu)–section 10–using analysis packages –heartbeat calcium scoring (hbcs). 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 24 july 2018.