X-RAY SYSTEMS FOR COMPUTERIZED TOMOGRAPHY, registration 10216710191, models: Brilliance 16-slice (Ar); Brilliance CT 64; Brilliance CT Big Bore; and, registration 10216710209, models: Ingenuity Core; Ingenuity Core 128; Ingenuity Flex. Risk class III. 의 안전성 경고

Safety alert

1713

2015-10-07

Brazil

ANVISA

http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp

Identified problems in software versions v3.6.1, v3.6.2, v3.6.4, v3.6.5 of the cited products which affect the performance of the equipment. this action involves 03 problems found as stated by the company: //// 1 - image position accuracy - the image rotation calibration program executed by the maintenance engineer can report an approval, but fails to generate the value of the correct angular rotation for ultrafast sweep mode. deviation from inaccurate angular rotation may impact the accuracy of radiation treatment planning. (models involved: brilliance 16-sleice (ar), brilliance ct big bore and ingenuity flex) /// 2 - tracker image artifact due to error in the reconstruction software - the image of the tracker scan of ct angiography (cta) may display an artifact at risk. because of the risk artifact, automatic clinical scanning may be triggered at the wrong time, resulting in unsatisfactory ct diagnostic images that do not capture the bolus peak of the displayed body section. (all models are involved) /// 3 - artifact circle / dot in the image due to x-ray measurement - after a complete shutdown and reclosing of the system, if a head sweep is performed without air calibration and without quick scanning of the iq check after activation, intermittent circle / dot artifacts may occur in the rebuilt images due to a firmware error. (models involved: brilliance 64 ct, ingenuity core and ingenuity core 128).

Philips will correct the errors by installing a software update on the affected systems. The company guides you: 1 - If you identify the image positioning problem described above, Philips suggests that you contact your service representative to perform the image rotation calibration. //// 2 - If you identify the artifact problem in scratches on the tracker image described above, there are three possible outcomes: a. The tracker image may not be affected by the artifact at risk and the scan will be triggered as expected. B. The artifact at risk can cause the tracker to be triggered in advance, generating unsatisfactory results, or; w. The tracker will not fire when the limit is reached. In this case, click "Manually trigger the clinical scan?" [Trigger clinical scan manually?] In the console user interface to start clinical scanning. //// 3 - If you identify an artifact in a circle or point during a head scan, Philips recommends performing a full calibration of the air before the next clinical scan. Action code: FCO72800635. SEE ANNEX LETTER TO THE CUSTOMER.