Philips Azurion 3 M15 Recall for 798 Units Worldwide Over Intermittent X-ray Imaging (2026)

How to identify if yours is affected

1. Verify system code is 722064, 722222, 722230, or 722280 (OUS only).
2. Check UDI: 00884838085282.
3. Review system serial numbers: 209, 238, 201, 258, 260, 261, 314, 229, 291, 270, 267, 218, 335, 513, 61, 161, 162, 169.

Where to find product info

Recall letter from Philips and the FDA recall page linked in Philips communications.

What timeline to expect

Recall remediation timelines typically run 4-8 weeks for refunds or replacements where applicable; for medical devices, service arrangements are made,

If the manufacturer is unresponsive

• Escalate to hospital administration or the device coordinator.
• Document all attempts to contact Philips and the healthcare provider.
• Consider filing complaints with the manufacturer and regulatory bodies if no response is received within stated timelines.

How to prevent similar issues

• In the future, verify device recalls for interventional imaging systems before use.
• Check for standard recall notices and ensure service contracts include recall coordination.
• Confirm replacement or service options through the manufacturer before use of any device in critical procedures.

Documentation advice

Keep a copy of the recall letter, record serial numbers and system codes, save all correspondence with Philips and healthcare providers, and document all service actions.