Azurion

Recalling firm

Philips New Zealand Commercial Limited

Product

Azurion. [Device]. Model: Philips Azurion R2.1.10 and 2.2.10 Systems; Philips Azurion R2.1.10 and 2.2.10 Systems.. Also covers: Angiographic X-Ray

Reason

The manufacturer has identified six software problems affecting Azurion R2.1.10 and R.2.10 systems that may result in loss of imaging (Xray) functionality, and/or loss of motorised movement, and/or incorrect image content, and/or loss of data., Problem 1- System keeps restarting, Problem 2- AMC triple drive firmware – leading to movement problems, Problem 3- C-Partition of Suite PC running out of free space, Problem 4- System remains in continuous restart mode after the start-up, Problem 5- Misalignment of Marker Tool Overlay, Problem 6 - 1- Longitudinal Position Error – Applicable only...

Classification

Class I

Category

medical device recall

Country

New Zealand

Agency

MEDSAFE

Recall date

2026-02-23

Status

Ongoing

Distribution

New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/bdb9aaa5-59fb-4513-9f94-d6e59346ec2b