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Philips Healthcare Recall 89750

Description: Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x

Philips Healthcare Recall 89750 Information

StatusOngoing
Mandated?FDA Mandated
Recall NumberZ-0737-2022
Event ID89750
Event DescriptionPhilips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x
Product TypeDevices
DistributionUS Nationwide distribution.
Quantity42 Systems
Recall ReasonDue to an incorrect configuration setting in the EPX database of StentBoost Live, acquisition does not stop automatically as it should. When the user selects the StentBoost Live protocol on the Philips Azurion system, the following on-screen message is displayed to the user in the Philips StentBoost Live application: "Press the cine pedal until the acquisition stops". However, due to the incorrect configuration of the EPX database, the acquisition does not stop after 40 images, but instead it continues as long as the pedal is pressed.
Device Classification20220413
Device Code InfoAzurion R2.1
Center Classification Date20220405
Recall Initiation Date20220202
Recalling FirmPhilips Healthcare
Initial Notification Letter
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