Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:23451
Brand Name:Philips Cleveland CT
Model:the Philips Brilliance iCT, Brilliance iCT SP, Ingenuity Core128, and Ingenuity CT
Affected:
Software version:
Recalling Organisation:Philips New Zealand Commercial Limited
Level 3
123 Carlton Gore Road
Newmarket
AUCKLAND 1023
Contact Information:0800 251 400
Manufacturer:Philips Medical Systems
Issue:It was reported that scanners running software versions 4.1.6 (Brilliance iCT and Ingenuity CT), with the Heartbeat CS Pro option provide confusing information in the Impressions section of the Calcium Score report. The generated report provides multiple analyses of the amount of plaque detected, as if they all apply to the patient at the same time.
Recall action type:Alert
Recall action:Manufacturer to issue advice regarding use
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:13/8/2018
Hide menus
Show menus
0 1 2 4 5 6 7 9 [ /