ProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref:706150
Published February 21, 2024 · Recall initiated: December 15, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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)
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips North America
- Distributor
- Nationwide Foreign: Australia Germany India Italy Malaysia Panama Thailand
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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