Date Initiated by Firm |
February 02, 2022 |
Create Date |
April 05, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0737-2022 |
Recall Event ID |
89750 |
510(K)Number |
K200917
|
Product Classification |
Interventional fluoroscopic x-ray system - Product Code OWB
|
Product |
Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x |
Code Information |
Azurion R2.1 |
Recalling Firm/ Manufacturer |
Philips Healthcare 3000 Minuteman Rd Andover MA 01810-1032
|
For Additional Information Contact |
Dusty Leppert 978-228-0190
|
Manufacturer 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.
|
FDA Determined Cause 2 |
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 in Commerce |
42 Systems |
Distribution |
US Nationwide distribution. |
Total Product Life Cycle |
TPLC Device Report
|
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
510(K) Database |
510(K)s with Product Code = OWB and Original Applicant = Philips Medical Systems Nederland BV
|