🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: December 15, 2023 Philips North America Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Philips North America
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)
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1073-2024

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