Philips Healthcare

Complete recall history across all FDA and CPSC categories — 21 total recalls

Philips Healthcare appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (21)

FDA medical device enforcement actions by Philips Healthcare

Date Product Reason Class
Aug 2, 2023 Incisive CT, software version 5.0 Philips has identified three software issues with compliance concerns to Subc... Class II
Feb 2, 2022 Philips StentBoost Live R2.0 application, when used with the Philips Azurion... Due to an incorrect configuration setting in the EPX database of StentBoost L... Class II
Sep 24, 2021 Philips Azurion systems with software releases 2.1(L1) and 2.1(L2) 3D-RA is a reconstruction software product that can be used with the Philips ... Class II
Sep 22, 2021 ProxiDiagnost N90 is multi-functional general R/F systems. The Aleva monitor requires certain labels to be applied, some of which are re... Class II
Sep 22, 2021 DigitalDiagnost C90 The Aleva monitor requires certain labels to be applied, some of which are re... Class II
Sep 22, 2021 CombiDiagnost R90 is multi-functional general R/F systems. The Aleva monitor requires certain labels to be applied, some of which are re... Class II
May 26, 2021 Azurion systems with software release R2.0.x In the Azurion system, the user can add a new study to a patient by selecting... Class II
Dec 21, 2018 DigitalDiagnost C50, Stationary X-ray System During recent evaluations of the Philips DigitalDiagnost C50 system, Philips ... Class II
Jun 11, 2018 Allura Xper Product Usage: Vascular,cardiovascular and neurovascular im... The first time an operator selects a new procedure type during a single exami... Class II
Jun 11, 2018 UNIQ Product Usage: Vascular,cardiovascular and neurovascular imaging a... The first time an operator selects a new procedure type during a single exami... Class II
Jun 11, 2018 Centron Product Usage: Vascular,cardiovascular and neurovascular imagin... The first time an operator selects a new procedure type during a single exami... Class II
Nov 10, 2015 Philips Healthcare DuraDiagnost stationary X-ray system The detector may signal that it is ready for acquisition when it actually is... Class II
Nov 10, 2015 Philips Healthcare DigitalDiagnost stationary X-ray system The detector may signal that it is ready for acquisition when it actually is... Class II
Sep 6, 2015 Philips Healthcare Ingenuity CT Computed Tomography X-Ray System Software Defects resulting in: (1) sagittal result shortened for axial scans;... Class II
Sep 6, 2015 Philips Healthcare Ingenuity Core Computed Tomography X-Ray System Software Defects resulting in: (1) sagittal result shortened for axial scans;... Class II
Sep 6, 2015 Philips Healthcare Ingenuity Core128 Computed Tomography X-Ray System Software Defects resulting in: (1) sagittal result shortened for axial scans;... Class II
Sep 6, 2015 Philips Healthcare Ingenuity Elite Computed Tomography X-Ray System Software Defects resulting in: (1) sagittal result shortened for axial scans;... Class II
Sep 6, 2015 Philips Healthcare Brilliance iCT SP Computed Tomography X-Ray System Software Defects resulting in: (1) sagittal result shortened for axial scans;... Class II
Sep 6, 2015 Philips Healthcare Brilliance 64 Computed Tomography X-Ray System Software Defects resulting in: (1) sagittal result shortened for axial scans;... Class II
Sep 6, 2015 Philips Healthcare Brilliance iCT Computed Tomography X-Ray System Software Defects resulting in: (1) sagittal result shortened for axial scans;... Class II
Jan 13, 2014 InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V... Phillips Healthcare initiated this action because the Main Control Board (MCB... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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