The Recall Desk

FDA (Devices) recall action 93966

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalled 3 products on 2024-02-28

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2024-02-28
Critical
0
Units
41

Why these products were recalled

Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) in PoInt EVR (Power Invertor). If a short circuit occurs, it will cause the fuses to trip and the system will become non-functional due to power loss, resulting in a potential delay of procedure or termination of procedure.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–3 of 3

  • HighFDA (Devices)··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.

    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
    Category
    Distribution
    7 states
  • HighFDA (Devices)··2024-02-28

    Azurion 5 X-Ray System Generator May Fail Due to Circuit Short

    Philips Azurion 5 X-ray systems with Certeray generators may experience power loss due to a potential short circuit in the power inverter board, potentially delaying or interrupting medical procedures.

    Product
    Azurion 5 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722227 (2) 722228
    Category
    Distribution
    7 states
  • HighFDA (Devices)··2024-02-28

    Philips Azurion 3 Surgical Imaging System Recalled for Power Failure Risk

    Philips is recalling 14 units of its Azurion 3 surgical imaging system due to a potential short circuit in the power inverter. The defect could cause the device to lose power and fail during surgical procedures.

    Product
    Azurion 3 with a Certeray generator -To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722221 (2) 722222 (3) 722280
    Category
    Distribution
    7 states