Brilliance Ic, Ingenuity Ct/ Ingenuity Core, Ingenuity Ct Systems

Recall Summary Philips CT imaging systems (Brilliance iC, Ingenuity CT, and related models) have a software problem that causes noisy, low-quality images when using X-series filters during cardiac scans. The affected systems are those running specific software versions that have been distributed to hospitals and laboratories in New Zealand. The noisy images may be unclear or not suitable for diagnosis, though alternative filters are available as a workaround.

Recalling firm
Philips New Zealand Commercial Limited
Product
Brilliance iC, Ingenuity CT/ Ingenuity Core, Ingenuity CT Systems. [Device]. Model: Brilliance iC, Ingenuity CT/ Ingenuity Core, Ingenuity CT and IQon Spectral CT; Brilliance iCT [iCT Elite with IMR, iCT Elite]� Rel 4.1.10 and IQon Spectral CT [IQon Spectral CT Pro, IQon Spectral CT Premium]; Ingenuity Core [CT 5000 Ingenuity Plus] Rel 4.1.10, Ingenuity Core 128 [CT 5000 Ingenuity Pro] Rel 4.1.10, Ingenuity CT� [CT 5000 Ingenuity Premium] Rel 4.1.10. Also covers: [MDR] Spectral CT, IQon Spectral CT, Brilliance iCT, Brilliannce iCT Upgrade; [MDR] Ingenuity Core, Ingenuity CT, Big Bore,...
Reason
The manufacturer has identified a software issue with the Philips iCT, Ingenuity CT, and Brilliance CT 64 systems that could affect the performance of the equipment. During the cardiac scan planning, if the X (XCA, XCB, XCC, XCD) filter for reconstruction is selected, the reconstructed cardiac images may display unexpected noise. Noisy cardiac images may result in reduced image quality, including recognizable artifacts, anatomy obscured by artifacts, or non-diagnostic images. As an alternative, instead of using X filter for cardiac imaging, you can use CA, CB, CC, and CD filters and...
Classification
Class I
Category
medical device recall
Country
New Zealand
Agency
MEDSAFE
Recall date
2026-08-31
Status
Ongoing
Distribution
New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/a9aaae93-09ad-4638-80d2-0c86f35fc6cf