The Recall Desk

FDA (Devices) recall action 93773

Philips North America recalled 2 products on 2024-02-21

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2024-02-21
Critical
0
Units
—

Why these products were recalled

Issue 1: Mixed Images: The Radio Fluoroscopy (RF) viewer may also display a previous patients radiography (RAD) images when starting the next patient scan while the previous patient image export is still processing. If the issue occurs, there is a potential for incorrect patient data to be displayed in the image. Issue 2: Detector Access point: Security vulnerability specific to the Wireless Portable Detector configuration items in Philips Support Connect (PSC). Due to this vulnerability it is possible, with physical access to the system and knowledge of specific settings, to modify and expor…

Issue 1: Mixed Images: The Radio Fluoroscopy (RF) viewer may also display a previous patient s radiography (RAD) images when starting the next patient scan while the previous patient image export is still processing. If the issue occurs, there is a potential for incorrect patient data to be displayed in the image. Issue 2: Detector Access point: Security vulnerability specific to the Wireless Portable Detector configuration items in Philips Support Connect (PSC). Due to this vulnerability it is possible, with physical access to the system and knowledge of specific settings, to modify and expo…

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

1–2 of 2

  • HighFDA (Devices)··2024-02-21

    Philips Recalls ProxiDiagnost Radiography Systems for Patient Data Display and Security Issues

    Philips is recalling 20 ProxiDiagnost radiography/fluoroscopy systems due to two issues: potential display of previous patient images when scanning new patients, and a security vulnerability allowing unauthorized data access. No injuries have been reported.

    Product
    ProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref:706150
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-02-21

    Philips ProxiDiagnost N90 X-ray System Recall for Patient Data and Security Issues

    Philips is recalling 138 U.S. units of its ProxiDiagnost N90 radiography system due to two identified issues. The system may display incorrect patient images during scan transitions, and a security vulnerability could allow unauthorized data access with physical device access.

    Product
    ProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref: (1)706100 (2)706110
    Category
    Distribution
    0 states