FDA Medical Device Recalls (openFDA)
Philips Healthcare: Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x
- Recall number
- Z-0737-2022
- Recalling firm
- Philips Healthcare
- Product
- Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x
- Status
- Terminated
- Initiated
- 2022-02-02
- Posted
- not on file
- Terminated
- 2024-11-05
- Reason
- 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.
- Root cause
- Radiation Control for Health and Safety Act
- 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.
- Quantity
- 42 Systems
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- Azurion R2.1
- 510(k) numbers
- ["K200917"]
- PMA numbers
- not on file
- Product code
- OWB
- Firm FEI
- 1218950
- Firm city
- Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28