The Recall Desk

Manufacturer

Philips Healthcare

21 recalls in our database name Philips Healthcare as the manufacturing or recalling firm.

What the numbers show

Total
21
Critical
0
Severe
0
Most recent
2023-10-11

Of the 21 recalls from Philips Healthcare we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–21 of 21

  • HighFDA (Devices)·Z-2520-2023·2023-10-11

    Philips Incisive CT Software Version 5.0 Recall for Scan Parameter Issues

    Philips is recalling Incisive CT software version 5.0 in 140 systems nationwide due to three compliance issues that may affect scan timing and imaging parameters.

    Product
    Incisive CT, software version 5.0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0737-2022·2022-04-13

    Philips StentBoost Live imaging system acquisition malfunction recall

    Philips Healthcare is recalling the StentBoost Live R2.0 application due to a software configuration error. The imaging system fails to stop image acquisition automatically, continuing indefinitely while the pedal is pressed instead of stopping after 40 images.

    Product
    Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0734-2022·2022-03-30

    Azurion Medical Imaging System Software Defect Affects Patient Dose Control

    Philips Azurion R2.1 systems have a software defect that causes the Patient Type to change unexpectedly when starting a procedure, potentially affecting dose control settings without user notification.

    Product
    Azurion systems with software release R2.0.x
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0238-2022·2021-12-01

    Philips Azurion System Recall for 3D Image Reconstruction Defect

    Philips Healthcare is recalling Azurion systems with software releases 2.1(L1) and 2.1(L2) due to a software defect that prevents proper reconstruction of 3D X-ray images when the detector is positioned outside required tolerance.

    Product
    Philips Azurion systems with software releases 2.1(L1) and 2.1(L2)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0239-2022·2021-12-01

    Medical imaging device missing required radiation safety labels

    Philips Healthcare is recalling DigitalDiagnost C90 medical imaging devices because some units lack required radiation warning labels and X-ray certification statements. Affected customers should contact Philips to have the missing labels applied.

    Product
    DigitalDiagnost C90
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0241-2022·2021-12-01

    Philips CombiDiagnost R90 X-ray systems missing required radiation warning labels

    Philips Healthcare is recalling CombiDiagnost R90 X-ray systems because some units lack required FDA radiation warning labels and X-ray certification statements. No injuries have been reported.

    Product
    CombiDiagnost R90 is multi-functional general R/F systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0240-2022·2021-12-01

    Medical X-Ray Systems Missing Required Radiation Warning Labels

    Philips Healthcare is recalling ProxiDiagnost N90 diagnostic X-ray systems that lack required FDA radiation warning labels. Some units nationwide were found missing the mandatory radiation safety labels and certification statements required by federal standards.

    Product
    ProxiDiagnost N90 is multi-functional general R/F systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2498-2019·2019-10-02

    Philips Recalls Two DigitalDiagnost C50 X-ray Systems for Missing Labels

    Philips Healthcare is recalling two DigitalDiagnost C50 stationary X-ray systems in Puerto Rico due to a missing label identified during recent evaluations.

    Product
    DigitalDiagnost C50, Stationary X-ray System
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2498-2018·2018-08-01

    Philips Allura Xper Medical Imaging Systems Recalled for Shutter Reset Issue

    Philips Healthcare is recalling 459 Allura Xper systems because shutter positions reset when procedure types change, potentially affecting imaging accuracy.

    Product
    Allura Xper Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive procedures. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2500-2018·2018-08-01

    Philips Centron Medical Imaging Systems Recalled for Shutter Reset Issue

    Philips Healthcare is recalling 459 Centron systems because shutter settings reset when procedure types change, potentially affecting imaging accuracy.

    Product
    Centron Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive procedures. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2499-2018·2018-08-01

    Philips Healthcare Recalls UNIQ Systems Due to Shutter Position Reset Issue

    Philips Healthcare is recalling 459 UNIQ systems because the shutter position resets to open when a new procedure type is selected, potentially losing previous settings.

    Product
    UNIQ Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive procedures. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA,st
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1718-2016·2016-06-15

    Philips Healthcare Ingenuity Core128 CT System Software Defect Recall

    Philips Healthcare is recalling 423 Ingenuity Core128 CT systems in the US due to software defects that cause incorrect scan lengths and dose calculations.

    Product
    Philips Healthcare Ingenuity Core128 Computed Tomography X-Ray System
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-1716-2016·2016-06-15

    Philips Healthcare Ingenuity Core CT System Software Defect Recall

    Philips Healthcare is recalling Ingenuity Core CT systems due to software defects that cause incorrect scan lengths and dose calculations.

    Product
    Philips Healthcare Ingenuity Core Computed Tomography X-Ray System
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-1714-2016·2016-06-15

    Philips Brilliance iCT CT System Software Defect Recall

    Philips Healthcare is recalling Brilliance iCT Computed Tomography X-Ray Systems due to software defects that cause incorrect scan lengths and dose calculations.

    Product
    Philips Healthcare Brilliance iCT Computed Tomography X-Ray System
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-1713-2016·2016-06-15

    Philips Brilliance 64 CT System Software Defect Recall

    Philips Healthcare is recalling 423 Brilliance 64 CT systems in the US due to software defects causing incorrect scan lengths and dose calculations.

    Product
    Philips Healthcare Brilliance 64 Computed Tomography X-Ray System
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-1715-2016·2016-06-15

    Philips Brilliance iCT SP CT System Recalled for Software Defects

    Philips Healthcare is recalling Brilliance iCT SP CT systems due to software defects that cause incorrect scan lengths and dose calculations.

    Product
    Philips Healthcare Brilliance iCT SP Computed Tomography X-Ray System
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-1696-2016·2016-06-15

    Philips DuraDiagnost X-ray System Recalled for Image Acquisition Failure

    Philips Healthcare is recalling five DuraDiagnost stationary X-ray systems because the detector may incorrectly signal readiness, causing failed image acquisitions.

    Product
    Philips Healthcare DuraDiagnost stationary X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1719-2016·2016-06-15

    Philips CT System Recalled for Software Defects Affecting Scan Accuracy

    Philips Healthcare is recalling Ingenuity Elite CT systems due to software defects that cause incorrect scan lengths and dose calculations.

    Product
    Philips Healthcare Ingenuity Elite Computed Tomography X-Ray System
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-1717-2016·2016-06-15

    Philips Ingenuity CT System Recalled for Software Defects

    Philips Healthcare is recalling Ingenuity CT systems due to software defects that cause incorrect scan lengths and dose calculations.

    Product
    Philips Healthcare Ingenuity CT Computed Tomography X-Ray System
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-0845-2014·2014-02-05

    Philips Healthcare Recalls InnerCool RTx Endovascular Systems Due to Temperature Reading Errors

    Philips Healthcare is recalling 50 InnerCool RTx Endovascular Systems because the main control board may display inaccurate low patient temperature readings and trigger false alarms.

    Product
    InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V). Product Usage: The InnerCool RTx device is a thermal regulating system intended to induce, maintain and reverse mild hypothermia, to achieve and/or maintain normothermia, and for use in fever redu
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Philips Healthcare

Division of Philips manufacturing healthcare equipment and providing related services

Source: Wikidata (Q4046835), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.