FDA-Device2024-02-21Class II

ProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref:706150

Philips North America
Hazard

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 export data to removable media (example: USB)

Sold states
Nationwide Foreign: Australia Germany India Italy Malaysia Panama Thailand
Affected count
20 units: 16 units US; 4 units OUS
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
ProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref:706150

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1073-2024

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