Alphenix (all Models)

Alphenix Recall Summary Canon Medical Systems Corporation is recalling all Alphenix models distributed to hospitals, pharmacies, and laboratories in New Zealand due to a need for a software upgrade. This is classified as a Class I recall, which indicates a serious issue. The recall affects the Alphenix equipment in medical facilities across New Zealand.

Recalling firm

Canon Medical Systems ANZ Pty Limited

Product

Alphenix (all models). [Device]. Model: Angiography system (INFX-8000C; INFX-8000V)

Reason

The manufacturer has identified that an internal error may occur when CAAS Clinical Functions are used during an examination, potentially causing a system lockup and loss of essential functions such as fluoroscopy and digital acquisition. Although a partial reset is recommended, the system may fail to restart due to temporary memory or storage read errors, leading to procedure interruptions or treatment delays that require a system restart.

Classification

Class I

Category

medical device recall

Country

New Zealand

Agency

MEDSAFE

Recall date

2026-05-01

Status

Ongoing

Distribution

New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/f805c6d8-3b2c-45b2-924d-223404a622a6