Azurion

Recalling firm

Philips New Zealand Commercial Limited

Product

Azurion. [Device]. Model: All Philips Azurion systems (R1.X, R2.X, R3.X, R4.0) are affected.; All Philips Azurion systems (R1.X, R2.X, R3.X, R4.0) are affected.. Also covers: Angiographic X-Ray

Reason

The manufacturer has identified a potential safety issue when the Reset Geometry button is configured to overwrite the table lock, while the Philips system is being used with a stand-alone third-party device or a stationary accessory not synchronized with the table (e.g., a floor-mounted device, a head stabilizer, a robotic arm with a biopsy needle). If the Reset Geometry button is then (accidentally) pressed, unintended table movement may cause the patient to move relative to the stand-alone third-party device or stationary accessory, posing a risk to the patient (e.g., if a needle is...

Classification

Class I

Category

medical device recall

Country

New Zealand

Agency

MEDSAFE

Recall date

2026-03-02

Status

Ongoing

Distribution

New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/463ab871-ac1f-4da2-986b-7952d322dd0e