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Philips Healthcare recalls

7 recalls recorded since 2018, most recently on 2 August 2023. 3 are listed as ongoing. Status and classification are as published by the FDA.

Recalls7

Ongoing (FDA)3

Terminated or completed4

Class I (FDA)0

Recall started: 2 August 2023
Reason: Philips has identified three software issues with compliance concerns to Subchapter J: Issue 1: Coronary Computed Tomography Angiography (CTA) scan may not be triggered at the optimal time. Issue 2: Use of aborted surview for scan planning will result in deviation from intended scan area. Issue 3: Actual clinical scan with bariatric (Noah) couch will deviate from the intended scan area if surview scan length is greater than 1832mm.
Distribution: US Nationwide Distribution
Initiated: FDA Mandated
Recall number: Z-2520-2023

Recall started: 2 February 2022
Terminated: 5 November 2024
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.
Distribution: US Nationwide distribution.
Initiated: FDA Mandated
Recall number: Z-0737-2022

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

Recall started: 24 September 2021
Reason: 3D-RA is a reconstruction software product that can be used with the Philips Azurin system. This product extends the functionality of compatible X-ray equipment with the capability of 3D X-ray imaging. Before starting a 3D-RA scan, the detector of the Philips Azurion system must be positioned in portrait or landscape orientation with an angle of 0 or +/-90 degrees relative to the 3D scan direction. Philips has discovered that Azurion releases 2.1(L1) and 2.1(L2) allow creation of a 3D-RA scan with a deviating detector orientation of up to 3 degrees from the exact portrait or landscape orientation (i.e., at 0 or +/-90 degrees), relative to the 3D scan direction. 3D-RA scans with a deviating detector orientation of ore than 1.0 degree from the exact portrait or landscape orientation (i.e., at 0 or +/-90 degrees) cannot be reconstructed with the 3D-RA reconstruction software.
Distribution: US Nationwide distribution
Initiated: FDA Mandated
Recall number: Z-0238-2022

Recall started: 22 September 2021
Reason: The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electronic Product Radiation Control performance standards. This includes the Radiation Warning Label [21CFR 1020.30 (j)] and the X-ray control certification statement [21 CFR 1010.2]. Philips has determined that some systems at customer locations did not have these labels applied.
Distribution: US Nationwide Distribution
Initiated: FDA Mandated
Recall numbers: Z-0241-2022, Z-0239-2022, Z-0240-2022

Recall started: 26 May 2021
Reason: In the Azurion system, the user can add a new study to a patient by selecting the option "Add Study". The Add Study dialogue box is then displayed where the Patient Type is selected to perform the study. Due to a software defect, when the study is initiated by pressing Start Procedure , the Patient Type changes inadvertently to a Patient Type different than the one selected as shown in the Table below. Patient type is one of the factors involved in the dose control process. The incorrect patient type changes the technique factors to be used by the system without notification to the user.
Distribution: US Nationwide Distribution
Initiated: FDA Mandated
Recall number: Z-0734-2022

Recall started: 21 December 2018
Terminated: 27 October 2020
Reason: During recent evaluations of the Philips DigitalDiagnost C50 system, Philips identified a missing label. This notification is intended to provide you with information regarding what the issue is, and relevant affected product, the actions you are required to take and the actions planned by Philips to correct the issue. If you need any or further information or support concerning this issue, please contact your local Philips representative or Philips Customer Service: 1-800-722-9377.
Distribution: Puerto Rico
Initiated: FDA Mandated
Recall number: Z-2498-2019

Recall started: 11 June 2018
Terminated: 3 July 2024
Reason: The first time an operator selects a new procedure type during a single examination,the shutter position resets to the open position for the new procedure type. If the shutters had previously been changed during the examination, that setting is not retained after the first time the procedure type is changed during a single examination.
Distribution: US Nationwide Distribution
Initiated: FDA Mandated
Recall numbers: Z-2500-2018, Z-2499-2018, Z-2498-2018

Centron Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive procedures. Cardiac imaging applications including diagnostics, in
UNIQ Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive procedures. Cardiac imaging applications including diagnostics, inter
Allura Xper Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive procedures. Cardiac imaging applications including diagnostics

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.