The Recall Desk
HighFDA (Devices)·Z-1178-2024·Announced 2024-02-28

Azurion 7 Medical Imaging System May Lose Power During Procedures

Philips Azurion 7 imaging systems may experience power loss due to a potential short circuit in the power inverter, risking delays or termination of diagnostic and surgical procedures.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device used in surgical and interventional procedures. The potential short circuit hazard could cause system failure and procedure interruption, representing a risk-of-harm product in a critical clinical setting. Although no injuries have been reported, the hazard is real and could occur during active procedures.

Plain-English summary

Philips Medical Systems has recalled Azurion 7 imaging systems with Certeray generators used for image guidance in diagnostic, interventional, and minimally invasive surgery procedures. The devices may experience power loss due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) within the Power Invertor (PoInt EVR). If a short circuit occurs, the fuses will trip and the system will lose power, making it non-functional.

This failure could result in delays to ongoing procedures or complete termination of procedures. The recall affects 10 units in the U.S. (distributed to NY, PA, PR, TN, TX, VA, and WA) and 124 units outside the U.S., distributed across multiple countries.

Healthcare facilities using affected Azurion 7 systems should contact Philips Medical Systems to verify whether their devices are included in this recall using the provided serial numbers and model information. Facilities should review their current procedures and consider backup imaging systems while working with the manufacturer to remediate or replace affected equipment.

The recalled product

Product
Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722223, (2) 722224, (3) 722225, (4) 722226
Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Medical Device — Surgical Imaging
Hazard

Distribution

Distributed nationwide across the United States.

The notice also names 7 states specifically:

Part of a larger recall action

This product is one of 3 recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

See all →

Same hazard · electrical short circuit

See all →