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.
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 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
- Hazard
- patient-misidentification
- data-breach
- security-vulnerability
Distribution
Distributed nationwide across the United States.
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