Iqon Spectral Ct System

Recalling firm

Philips New Zealand Commercial Limited

Product

IQon Spectral CT System. [Device]. Model: Philips IQon Spectral CT Systems - Product Code: 728332; CT5000 Ingenuity Plus, CT5000 Ingenuity Pro, CT5000 Ingenuity Premium - Product code : 728321, 728323, 728326; Brilliance CT 64 system, Brilliance iCT - Product code: 728306, 728231. Also covers: Ingenuity CT System; Brilliance iCT Systems

Reason

The manufacturer has identified a software issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment., During a bolus-tracking scan, after the user starts the Tracker scan following Surview and Locator acquisitions, the Tracker graph and images may fail to update or display when the contrast agent attenuation (CT value) at the ROI (region of interest) reaches the preset threshold. As a result, additional Tracker scans may be performed on the patient, and the clinical scan may not automatically start once the threshold is...

Classification

Class I

Category

medical device recall

Country

New Zealand

Agency

MEDSAFE

Recall date

2026-03-26

Status

Ongoing

Distribution

New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/60209889-a944-433d-83ce-3c8c8217bd5f