Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x
Summary
The FDA issued a Class II for Philips StentBoost Live R2.0 application, when used with the Philips Azurion wi by Philips Healthcare. 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 .
Details
Source
Device Recall
External ID
Z-0737-2022
Action Date
2022-04-13
Status
Terminated
Category
device
Product Description
Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x
Lot/Code Info: Azurion R2.1
Quantity Affected: 42 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.
Distribution
US Nationwide distribution.
Type: FDA Mandated
Recall Initiated: 2022-02-02
Company
Andover, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 149 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Philips Healthcare has 7 FDA actions in our database, including 7 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Philips Healthcare) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Philips Healthcare have FDA actions?
Philips Healthcare has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0737-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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