[mdr] Azurion

Recalling firm

Philips New Zealand Commercial Limited

Product

[MDR] Azurion. [Device]. Model: Philips Azurion R3.1 Systems

Reason

The manufacturer has become aware of an anomaly with the Philips Azurion R3.1 Systems., Issue 1 - System remains in continuous restart mode after the start-up Due to a software issue, the License Manager – which verifies installed licenses and enables optional functionality in the Azurion system based on the available licenses – expands the Windows registry database at every system start or restart., Issue 2 - Longitudinal Position Error – Applicable only to Azurion systems with Poly-G3 frontal stand When requesting a movement of the frontal stand in longitudinal direction, the Azurion...

Classification

Class I

Category

medical device recall

Country

New Zealand

Agency

MEDSAFE

Recall date

2026-08-03

Status

Ongoing

Distribution

New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/2dbea994-9805-4a5b-8c37-ce0aa779c19a