Philips Health Care
Country not established
- Devices
- 21
- FDA recalls
- 1705 ongoing
At a glance
Market reach
- United States
- FDA recalls
What Philips Health Care makes
The company manufactures diagnostic ultrasound systems, including portable and advanced imaging devices like the Lumify, CLEARVUE 350/550, CX50, and Sparq, as well as specialized software for cardiac analysis such as QLAB Quantification Software and 3D Auto LAA. It also produces MRI systems (ACHIEVA R4 1.5T and 3.0T), ECG monitoring solutions (INTELLISPACE ECG, CALG-STR algorithm), and a catheter navigation system (PERCUNAV). Collaboration tools for medical imaging, such as Collaboration Live, are also part of the portfolio.
These devices are classified under Class II in the US and are listed via FDA 510(k) submissions. The company is based in the United States.
Catalogue
Search and filter all 21 devicesFDA recalls
FDA recall records list 170 recalls initiated by Philips Health Care, the earliest on 2009-03-30 and the most recent on 2023-08-02. By recorded status: 5 ongoing, 164 terminated and 1 with another status. The reasons filed fall into these groups: electrical or power. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 4
- 2019 0
- 2020 0
- 2021 5
- 2022 1
- 2023 1
- 2024 0
- 2025 0
- 2026 0
2023
- 2 Aug 2023 Z-2520-2023 Class II Ongoing 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.
2022
- 2 Feb 2022 Z-0737-2022 Class II Terminated 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.
2021
- 24 Sep 2021 Z-0238-2022 Class II Ongoing 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.
- 22 Sep 2021 Z-0239-2022 Class II Ongoing 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.
- 22 Sep 2021 Z-0240-2022 Class II Ongoing 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.
- 22 Sep 2021 Z-0241-2022 Class II Ongoing 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.
- 26 May 2021 Z-0734-2022 Class II Completed 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.
2018
- 21 Dec 2018 Z-2498-2019 Class II Terminated 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.
- 11 Jun 2018 Z-2498-2018 Class II Terminated 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.
- 11 Jun 2018 Z-2499-2018 Class II Terminated 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.
Show the 25 most recent of 170 recalls
2018
- 11 Jun 2018 Z-2500-2018 Class II Terminated 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.
2015
- 10 Nov 2015 Z-1695-2016 Class II Terminated The detector may signal that it is ready for acquisition when it actually is not, resulting in failure to properly acquire the X-ray image.
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- 10 Nov 2015 Z-1696-2016 Class II Terminated The detector may signal that it is ready for acquisition when it actually is not, resulting in failure to properly acquire the X-ray image.
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- 6 Sep 2015 Z-1713-2016 Class II Terminated Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a change in field of view; (4) DoseRight algorithm miscalculations leading to incorrect CTDI values; (5) scan length changes during subsequent axial results, (6) surview scan lengths near 135mm or 184mm
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- 6 Sep 2015 Z-1714-2016 Class II Terminated Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a change in field of view; (4) DoseRight algorithm miscalculations leading to incorrect CTDI values; (5) scan length changes during subsequent axial results, (6) surview scan lengths near 135mm or 184mm
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- 6 Sep 2015 Z-1715-2016 Class II Terminated Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a change in field of view; (4) DoseRight algorithm miscalculations leading to incorrect CTDI values; (5) scan length changes during subsequent axial results, (6) surview scan lengths near 135mm or 184mm
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- 6 Sep 2015 Z-1716-2016 Class II Terminated Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a change in field of view; (4) DoseRight algorithm miscalculations leading to incorrect CTDI values; (5) scan length changes during subsequent axial results, (6) surview scan lengths near 135mm or 184mm
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- 6 Sep 2015 Z-1717-2016 Class II Terminated Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a change in field of view; (4) DoseRight algorithm miscalculations leading to incorrect CTDI values; (5) scan length changes during subsequent axial results, (6) surview scan lengths near 135mm or 184mm
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- 6 Sep 2015 Z-1718-2016 Class II Terminated Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a change in field of view; (4) DoseRight algorithm miscalculations leading to incorrect CTDI values; (5) scan length changes during subsequent axial results, (6) surview scan lengths near 135mm or 184mm
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- 6 Sep 2015 Z-1719-2016 Class II Terminated Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a change in field of view; (4) DoseRight algorithm miscalculations leading to incorrect CTDI values; (5) scan length changes during subsequent axial results, (6) surview scan lengths near 135mm or 184mm
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- 10 Nov 2015 Z-1695-2016 Class II Terminated The detector may signal that it is ready for acquisition when it actually is not, resulting in failure to properly acquire the X-ray image.
2014
- 13 Jan 2014 Z-0845-2014 Class II Terminated Phillips Healthcare initiated this action because the Main Control Board (MCB) may produce an inaccurate low patient temperature reading and low temperature alarm.
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- 13 Jan 2014 Z-0845-2014 Class II Terminated Phillips Healthcare initiated this action because the Main Control Board (MCB) may produce an inaccurate low patient temperature reading and low temperature alarm.
2013
- 8 Aug 2013 Z-2059-2013 Class II Terminated The mirror icon on the bottom of each image could be misinterpreted as a RIGHT lead marker for side indication if the image is mirrored within a PACS system.
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- 8 Jul 2013 Z-1780-2013 Class II Terminated IntelliVue Smart-hopping 1.4 GHz Access Point may experience unexpected signal loss of several minutes impacting wireless connectivity
- 19 Jun 2013 Z-1797-2013 Class II Terminated The MRx may deliver a non-synchronized cardioversion shock resulting in the delivery of incorrect therapy, which may induce ventricular fibrillation.
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- 11 Jun 2013 Z-1964-2013 Class II Terminated The Instructions for Use (IFU) for the MobileDiagnost wDR fails to comply with a Federal standard. The IFU does not provide tolerance levels for several generator values as required by 1020.30(h)(3).
- 8 Aug 2013 Z-2059-2013 Class II Terminated The mirror icon on the bottom of each image could be misinterpreted as a RIGHT lead marker for side indication if the image is mirrored within a PACS system.
Frequently asked questions
How many devices does Philips Health Care have in the registry?
The registry currently lists 21 devices for Philips Health Care. Devices recorded under merged duplicate company entries are counted once.
Which registries list Philips Health Care's devices?
Among its 21 most recently registered devices, Philips Health Care has devices listed in FDA 510(k) (21 devices).
What risk classes do Philips Health Care's devices fall under?
Among its 21 most recently registered devices, the classes recorded for Philips Health Care's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Philips Health Care?
FDA recall records list 170 recalls initiated by Philips Health Care, the most recent initiated on 2 Aug 2023. 5 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Philips Health Care in the registry?
The most recently registered devices listed for Philips Health Care include ST80I STRESS TEST SYSTEM, Philips Lumify Diagnostic Ultrasound System, QLAB Advanced Quantification Software and Philips EPIQ 5 Diagnostic Ultrasound System.