medical Class II Updated 2024-02-21

Philips North America recalls ProxiDiagnost upgrade- A Multi-functional general Radiograph

Recalled Product

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


Hazard / Issue

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)

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI: N/A Serial Numbers US: 4 5 6 7 8 9 11 12 13 14 17 18 61 692222229 692222254 692222263 Serial Numbers OUS: 53 56 65 692222227
View official government recall

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