The Recall Desk
HighFDA (Devices)·Z-1073-2024·Announced 2024-02-21

Philips Recalls ProxiDiagnost Radiography Systems for Patient Data Display and Security Issues

Philips is recalling 20 ProxiDiagnost radiography/fluoroscopy systems due to two issues: potential display of previous patient images when scanning new patients, and a security vulnerability allowing unauthorized data access. No injuries have been reported.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall addressing two potential hazards with risk of patient harm: mixed patient image display could lead to clinical errors, and security vulnerability could enable unauthorized data access. No illnesses or injuries have been reported.

Plain-English summary

Philips North America is recalling 20 ProxiDiagnost upgrade systems (model Ref: 706150)—multi-functional radiography and fluoroscopy imaging devices used in medical facilities. Sixteen units were distributed in the United States, with four units distributed internationally to Australia, Germany, India, Italy, Malaysia, Panama, and Thailand.

The recall addresses two separate issues. The radiography viewer may display images from a previous patient when starting a scan for the next patient if the previous patient's image export is still processing. This could result in incorrect patient data being shown. Additionally, a security vulnerability in the Wireless Portable Detector configuration within Philips Support Connect could allow someone with physical access and knowledge of specific settings to modify and export data to removable media such as USB drives.

Facilities operating affected units should contact Philips North America for remediation guidance. No injuries or illnesses related to these issues have been reported.

The recalled product

Product
ProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref:706150
Manufacturer
Philips North America
Hazard
  • mixed-patient-images
  • unauthorized-data-access

Distribution

Distributed nationwide across the United States.