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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Philips North America under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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