Agency classClass IIOur severity:High FDA (Devices)·Z-1072-2024·Announced 2024-02-21

Philips ProxiDiagnost N90 X-ray System Recall for Patient Data and Security Issues

Philips is recalling 138 U.S. units of its ProxiDiagnost N90 radiography system due to two identified issues. The system may display incorrect patient images during scan transitions, and a security vulnerability could allow unauthorized data access with physical device access.

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 medical device recall with two identified issues—incorrect patient image display creating misidentification risk, and a data security vulnerability requiring physical access. No adverse events or breaches have been reported, meeting the criteria of a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Philips is recalling 138 units of the ProxiDiagnost N90, a multi-functional radiography and fluoroscopy imaging system, in the United States, plus 13 additional units internationally.

The first issue involves the Radio Fluoroscopy viewer, which may display a previous patient's radiography images when a new patient scan is initiated while the previous patient's image export is still processing. If this occurs, incorrect patient data could be displayed in the image, creating a risk of patient misidentification.

The second issue is a security vulnerability in the Wireless Portable Detector configuration within Philips Support Connect. With physical access to the system and knowledge of specific settings, an unauthorized person could potentially modify system settings and export patient data to removable media such as USB drives. No adverse events or data breaches have been reported.

The recalled product

Product: ProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref: (1)706100 (2)706110
Manufacturer: Philips North America
Category: Medical Device — Radiography and Fluoroscopy System
Hazard: patient-misidentification
data-breach
security-vulnerability

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.

See all 2 products in this recall →

Same manufacturer · Philips North America

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Same hazard · patient misidentification