[mdr] Spectral Ct, Iqon Spectral Ct, Brilliance Ict, Brilliannce Ict Upgrade
- Recalling firm
- Philips New Zealand Commercial Limited
- Product
- [MDR] Spectral CT, IQon Spectral CT, Brilliance iCT, Brilliannce iCT Upgrade. [Device]. Model: Spectral CT
- Reason
- As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced.
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-01-30
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/f415f481-c812-465f-ac77-a906e2a4b34f