PharmacovigilanceOfficial

Philips warns Azurion systems may contain unspecified SSDs fitted during repair or servicing

🇳🇱 IGJ · Sun 08 Nov 2026

The Dutch inspectorate IGJ has published a Philips field safety notice saying some Azurion image-guided therapy systems may have been fitted with solid-state drives not listed in the medical device file.

The Dutch health and youth care inspectorate IGJ has published a manufacturer warning from Philips Medical Systems Nederland BV concerning its Azurion systems. The notice is dated 3 November 2026, and the IGJ posting carries a date of 9 November 2026.

Azurion systems use solid-state drives (SSDs) in several of their PCs. The drives hold the operating system and image data and support system operation, according to the notice.

Philips has found that, during certain repair or servicing activities, SSDs may have been installed that are not specified in the medical device file. According to the notice, such drives may have different performance characteristics and could become less reliable over time.

The IGJ page links to a five-page PDF containing the field safety notice. The text available here does not describe the specific actions Philips asks of users, nor which systems, serial numbers or service events are affected. It also gives no reports of harm.

IGJ notes that manufacturers must monitor devices after they reach the market and improve them where necessary. Where a risk to users exists, they must take action and inform both users and the inspectorate through a Field Safety Notice.

What it means for your team

  • Hospitals and service organisations operating Azurion systems should read the full FSN to establish whether their units are affected and what action is required.
  • Quality teams should check service and repair records for non-specified SSD replacements, since the issue stems from servicing activities rather than original manufacture.
  • The issue is one of configuration control: parts installed during servicing must match those in the medical device file.
  • Vigilance teams should confirm that any related incidents are logged and reported through the usual channels.

Official source: IGJ ↗

Article written by VigiEye from the official source (IGJ). AI-assisted; check the source before acting.

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