The Recall Desk

Manufacturer

Philips North America, LLC

410 recalls in our database name Philips North America, LLC as the manufacturing or recalling firm.

What the numbers show

Total
410
Critical
2
Severe
26
Most recent
2026-09-09

Of the 410 recalls from Philips North America, LLC we have scored against our rubric, 2 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 26 (6%) 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.

26–50 of 410

  • HighFDA (Devices)·Z-0858-2026·2025-12-10

    IntelliVue MP90 monitors recalled because an alarm may not sound

    Philips North America is recalling the IntelliVue MP90 over a potential issue where the monitors did not alarm.

    Product
    IntelliVue MP90. Product Number: M8010A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0881-2026·2025-12-10

    Incisive CT systems recalled because tube heat exchanger screws may not be tightened

    Philips North America is recalling 2,341 Incisive CT systems because a tube heat exchanger whose screws are not tightened after replacement may detach and damage other components.

    Product
    Incisive CT; Software Version Number: 4.5, 5.0, 5.1;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0882-2026·2025-12-10

    CT scanners recalled because tube heat exchanger screws may not be tightened

    Philips North America is recalling 6 CT 5300 systems because a tube heat exchanger whose screws are not tightened after replacement may detach and damage other components.

    Product
    CT 5300; Software Version Number: 4.5, 5.0, 5.1;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0861-2026·2025-12-10

    DHEA tests recalled for distribution without premarket approval or clearance

    Get Tested International AB is recalling 17 units of its DHEA Test because the product was distributed without premarket approval or clearance.

    Product
    IntelliVue Patient Monitor MX100. Product Number: 867033.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0860-2026·2025-12-10

    Peptic ulcer H. pylori tests recalled for lacking premarket approval or clearance

    Get Tested International AB is recalling 12 units of its Peptic Ulcer Test (H. pylori) because the product was distributed without premarket approval or clearance.

    Product
    IntelliVue Multi-Measurement Module X3. Product Number: 867030.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2595-2025·2025-10-01

    Brilliance CT 40 and 64 channel systems recalled over unexpected couch descent

    Philips Brilliance CT 40 Channel, Brilliance CT 64 Channel and Ingenuity Flex systems are recalled because the patient support table may descend unexpectedly after a ball screw replacement. 181 units are affected.

    Product
    Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, Model Number: 728235. 2. Brilliance CT 64 Channel, Model Number: 728231. 3. Ingenuity Flex, Model Number: 728317
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2599-2025·2025-10-01

    Philips Brilliance iCT SP CT Systems Patient Support Table Descent

    Philips is recalling Brilliance iCT SP CT systems due to a ball screw misalignment that may cause the patient support table to descend unexpectedly to its lowest position.

    Product
    Philips CT systems labeled as the following: 1. Brilliance iCT SP, Model Number: 728311.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2602-2025·2025-10-01

    Philips CT Systems Patient Support Table May Descend Unexpectedly

    Philips is recalling certain CT systems because the patient support table may descend unexpectedly to the lowest position due to a component misalignment during replacement.

    Product
    Philips CT systems labeled as the following: 1. Ingenuity Core128 / Elite China, Model Number: 728324.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2596-2025·2025-10-01

    Brilliance 16 and 6 slice scanners recalled over patient table descent

    Philips Brilliance 16 Power, Brilliance CT 16 Slice and Brilliance CT 6 Slice systems are recalled because the patient support table may descend unexpectedly after a ball screw replacement. 73 units are affected.

    Product
    Philips CT systems labeled as the following: 1. Brilliance 16 Power, Model Number: 728240. 2. Brilliance CT 16 Slice, Model Number: 728246. 3. Brilliance CT 6 Slice, Model Number: 728256.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2601-2025·2025-10-01

    IQon Spectral CT recalled over ball screw misalignment lowering the couch

    Philips IQon Spectral CT systems, model 728332, are recalled because the patient support table may descend unexpectedly due to ball screw misalignment after a replacement. 81 units are affected.

    Product
    Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2604-2025·2025-10-01

    CT 6000 scanners recalled because the patient table may drop unexpectedly

    Philips CT 6000 systems, model 728307, are recalled because the patient support table may descend unexpectedly due to ball screw misalignment after a replacement. 6 units are affected.

    Product
    Philips CT systems labeled as the following: 1. CT 6000, Model Number: 728307.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2600-2025·2025-10-01

    Ingenuity CT scanners recalled because the patient couch may descend unexpectedly

    Philips Ingenuity CT systems are recalled because the patient support table may descend unexpectedly to its lowermost position due to ball screw misalignment after a replacement. 285 units are affected.

    Product
    Philips CT systems labeled as the following: 1. Ingenuity CT 728326, Model Number: 728321. 2. Ingenuity CT 728326, Model Number: 728323. 3. Ingenuity CT, Model Number: 728326.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2603-2025·2025-10-01

    Ingenuity CT Brazil family recalled over patient table descending to lowermost position

    Philips Ingenuity CT Family Brazil systems, model 728325, are recalled because the patient support table may descend unexpectedly due to ball screw misalignment after a replacement. 3 units are affected.

    Product
    Philips CT systems labeled as the following: 1. Ingenuity CT Family Brazil, Model Number: 728325.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2597-2025·2025-10-01

    Big Bore CT systems recalled because patient table may descend unexpectedly

    Philips Big Bore RT, Brilliance CT Big Bore Oncology and Brilliance CT Big Bore systems are recalled because the patient support table may descend unexpectedly after a ball screw replacement. 33 units are affected.

    Product
    Philips CT systems labeled as the following: 1. Big Bore RT, Model Number: 728242. 2. Brilliance CT Big Bore Oncology, Model Number: 728243. 3. Brilliance CT Big Bore, Model Number: 728244.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2598-2025·2025-10-01

    Brilliance iCT systems recalled over ball screw misalignment dropping the couch

    Philips Brilliance iCT systems, model 728306, are recalled because the patient support table may descend unexpectedly after a ball screw replacement. 210 units are affected.

    Product
    Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2034-2025·2025-07-02

    Philips Spectral CT Computed Tomography X-ray System Software

    Philips Spectral CT systems with affected software may experience unintended motion of the gantry or table that could lead to contact with operators or patients. Additional software issues may also affect CT performance.

    Product
    Spectral CT. Computed tomography X-ray system.
    Category
    Medical Device
    Distribution
    19 states