The Recall Desk
HighFDA (Devices)·Z-0737-2022·Announced 2022-04-13

Philips StentBoost Live imaging system acquisition malfunction recall

Philips Healthcare is recalling the StentBoost Live R2.0 application due to a software configuration error. The imaging system fails to stop image acquisition automatically, continuing indefinitely while the pedal is pressed instead of stopping after 40 images.

What this means for you

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: This is an FDA Class II medical device recall involving a software malfunction that affects diagnostic imaging functionality. While the device failure could impact clinical decision-making, no injuries, illnesses, or patient harm has been reported. Per the severity rubric, risk-of-harm products without reported injury are scored as High (3).

Plain-English summary

Philips Healthcare is recalling the StentBoost Live R2.0 application when used with Philips Azurion systems running software version R2.x. The application contains an incorrect configuration setting in its EPX database that prevents automatic termination of image acquisition.

When a user selects the StentBoost Live protocol, the system displays instructions to "Press the cine pedal until the acquisition stops." However, due to the database misconfiguration, the acquisition continues for as long as the pedal remains pressed, rather than stopping after 40 images as designed. This malfunction could result in extended imaging sessions and potentially impact the quality and completeness of diagnostic imaging during interventional cardiology procedures.

Approximately 42 systems are affected by this issue and distributed nationwide throughout the United States. Healthcare facilities operating this equipment should contact Philips Healthcare for available software corrections and updated configuration guidance.

The recalled product

Product
Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x
Manufacturer
Philips Healthcare
Category
Medical Device — Interventional Cardiology Imaging System
Hazard
  • software-misconfiguration
  • acquisition-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Azurion R2.1

Distribution

Distributed nationwide across the United States.

Related recalls

Same category