Philips VesselNavigator Software Recall for DSA Display Defect
Philips is recalling VesselNavigator software due to a defect that displays digital subtraction angiography images without subtraction.
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: The recall involves a software defect in a medical device used during procedures, representing a risk-of-harm product where injury has not yet been reported, consistent with the High severity criteria.
Plain-English summary
Philips North America, LLC is recalling the VesselNavigator application used with Philips Azurion and Allura Xper systems. The recall involves 443 units distributed worldwide, including the United States, Canada, and numerous other countries.
The recall is due to a software defect where digital subtraction angiography (DSA) images exported to the VesselNavigator application are displayed without subtraction. This software is used during endovascular intervention procedures.
Healthcare facilities should contact Philips for instructions on how to resolve the software defect. The source text does not report any illnesses or injuries associated with this defect.
The recalled product
- Product
- VesselNavigator application used with Philips Azurion (Azurion 7 Series) Software R1.2 and R2.0, and Philips Allura Xper R9, upgraded to Azurion 1.2 M20. System codes: Azurion 7 B12 (722067), Azurion 3 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079), Field…
- Manufacturer
- Philips North America, LLC
- Category
- Medical Device — Software
- Affected units
- 443
Distribution
Distributed nationwide across the United States.
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