Philips Allura and Azurion X-ray systems may display incorrect previous images
Philips Allura and Azurion X-ray systems running StentBoost Live R2.0 may display images from previous scans or other patients due to a software defect. 338 units are affected and globally distributed.
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 with a software defect that could display incorrect or previous patient images, presenting a risk-of-harm scenario during cardiac intervention. No illnesses or injuries have been reported.
Plain-English summary
Philips is recalling Allura and Azurion X-ray imaging systems running StentBoost Live software (version R2.0) due to a software defect. Affected model numbers include Allura 722010, 722012, 722026, 722027, 722028, 722029, and 722035; and Azurion 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, and 722228. A total of 338 units have been distributed globally, including throughout the United States.
The StentBoost Live R2.0 software contains a defect that may prevent the system from processing X-ray images of the current examination. When this occurs, the system displays an image that was processed in a previous examination instead. The displayed image may be from the same patient or from a different patient.
Healthcare facilities using affected Philips X-ray systems are at risk from this defect. The systems are used in hospitals and cardiac catheterization laboratories. Healthcare providers should verify whether their equipment model and serial numbers match those identified in this recall.
Affected healthcare facilities should contact Philips for software updates or remediation instructions. Verify the model number and serial number of your equipment against the recall details provided by the FDA. Clinicians should be aware of this potential image processing defect when using these systems until the issue is resolved.
The recalled product
- Product
- Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Azurion (Model Numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228) running StentBoost Live (Model Number…
- Manufacturer
- Philips North America Llc
- Affected units
- 338
Distribution
Distributed nationwide across the United States.
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