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Terminated

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

FDA Recall Z-0737-2022 · Posted None

Recalling FirmPhilips Healthcare
Recall StatusTerminated
Product CodeOWB
Date Initiated2022-02-02
Date Terminated2024-11-05
Product Quantity42 Systems

Reason for Recall

Due 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.

Firm Action

Philips notified customers of the issue via an Electronic Product Radiation Defect notification letter dated February 2, 2022. Philips will schedule an appointment with customers to install the software update. Philips will correct the affected systems at no cost to customers with a software upgrade. For information contact your local Philips representative: 1-800-722-9377.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

US Nationwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K200917Azurion R2.1Philips Medical Systems Nederland B.V. · 2020-05-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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