[mdr] Spectral Ct, Iqon Spectral Ct, Brilliance Ict, Brilliannce Ict Upgrade

Recall Summary Philips is recalling certain CT scanner models (Spectral CT, IQon Spectral CT, Brilliance iCT, and Brilliance iCT Upgrade) with specific software versions due to multiple technical issues. The problems include image quality defects during certain scan types, incorrect measurements in some reconstructed images, unexpected movement of the scanner couch during procedures, and potential rotor rotation hazards during maintenance. This recall affects CT systems used in hospitals and laboratories in New Zealand.

Recalling firm

Philips New Zealand Commercial Limited

Product

[MDR] Spectral CT, IQon Spectral CT, Brilliance iCT, Brilliannce iCT Upgrade. [Device]. Model: Philips Spectral CT with software version V5.0, V5.2, or V5.4; Philips Spectral CT with software version V5.0, V5.2, or V5.4. Affected: Product code: 728333; Product code: 728333. Also covers: BEST CT Systems

Reason

Philips has identified software issues that may affect the safety and performance of certain CT systems:, 1., Image artefacts at 80 kVp: Hyperdense, hypodense, or other image quality artefacts may occur during 80 kVp scans., 2. Image artefacts in off-centre brain scans: Brain scans performed with the head positioned off-centre may exhibit image artefacts in the bone-brain area., 3. Incorrect slice thickness with EFOV: Images reconstructed using an extended field of view (EFOV) may have an actual slice thickness different from the displayed value., 4., Unexpected couch movement: During...

Classification

Class I

Category

medical device recall

Country

New Zealand

Agency

MEDSAFE

Recall date

2026-09-10

Status

Ongoing

Distribution

New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/107ce0fc-8f2a-402e-b2f7-2ea7b074eb55