Official recall record

Philips Azurion system; Software Version Number: R3.1;

What the authority reported

Philips has identified two (2) software issues affecting device systems that may result in loss of imaging (X-ray) functionality and/or loss of motorized movement, and/or incorrect image content and/or loss of data. Issue 1 - System remains in continuous restart mode after the start-up. Issue 2 - Longitudinal Position Error Applicable only to systems with Poly-G3 frontal stand.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

More recalls: US FDA — Medical Devices · Netherlands · all filters

Same barcode in other registries

The same EAN appears in 3 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.

• 2024-02-06 · US FDA — Medical Devices
  Azurion 3 with a Certeray generator -To perform image guidance in diagnostic, interventional, and minimally invasive sur
• 2026-03-31 · US FDA — Medical Devices
  Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M15 (722222, 722230),
• 2023-12-07 · US FDA — Medical Devices
  Philips Azurion 3M12, Model Numbers: 722063, 722221 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with

Other recalls from this brand

• 2026-07-16 · US FDA — Medical Devices
  Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223
• 2026-07-16 · US FDA — Medical Devices
  Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Soft

All 73 official recall notices naming PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. on this site →