Angiographic X-ray

Recalling firm: Philips New Zealand Commercial Limited
Product: Angiographic X-Ray. [Device]. Model: a Philips Azurion R2.x.10, R3.0, R3.1 and R4.0 systems; Azurion R3.0 systems are affected by these issues. Issue 2 - Loss of geometry movements only affects Azurion R3.0 systems equipped with an AD7X patient table.. Also covers: [MDR] Azurion
Reason: The manufacturer has identified 2 potential problems that may lead to delay of therapy, procedural complications and/or inappropriate treatment., · Problem 1: Image quality degradation, A problem associated with the Flat Detector Controller System Interface Board (FDCSIB), may result in image artifacts during, system operation. The observed artifacts may include black and white dot noise, grainy or cloudy image quality, snow-like, effects, and random pixelation., · Problem 2: Loss of geometry movements – Applicable to systems with an AD7X table only, In some cases, following a system...
Classification: Class I
Category: medical device recall
Country: New Zealand
Agency: MEDSAFE
Recall date: 2026-08-10
Status: Ongoing
Distribution: New Zealand - Hospital/Pharmacy/Laboratory

Recall details on Nibble Recalls: https://trynibble.app/recalls/d72976ca-1f0b-424a-9e2f-cf56cf25ac6f