PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: February 21, 2024 Initiated: December 15, 2023 #Z-1073-2024

Product Description

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

Reason for Recall

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)

Details

Recalling Firm
Philips North America
Units Affected
20 units: 16 units US; 4 units OUS
Distribution
Nationwide Foreign: Australia Germany India Italy Malaysia Panama Thailand
Location
Cambridge, MA

Frequently Asked Questions

What product was recalled?
ProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref:706150. Recalled by Philips North America. Units affected: 20 units: 16 units US; 4 units OUS.
Why was this product 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 export data to removable media (example: USB)
Which agency issued this recall?
This recall was issued by the FDA Devices on February 21, 2024. Severity: Moderate. Recall number: Z-1073-2024.