Drugs & medicalClass II

Philips North America recalls Cardiac Workstation 5000; Model Number: 860439;

Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short.

Read the official notice →
Date
2025-10-22
Country
United States
Brand
Philips
Product
Cardiac Workstation 5000; Model Number: 860439;
Classification
Class II
Units
US Nationwide distribution in the states of CA, IA, TN, TX, VA.
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Philips recalls

  1. 2025-12-17
  2. US
    Drugs & medicalClass II

    Philips North America recalls Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM

    Between July 2024 and June 2025, Philips Azurion R3.0 systems with a FlexArm stand were shipped without the Source-to-Skin Distance (SSD) Spacer. The SSD spacer is necessary to meet the FDA minimum source-skin distance…

    FDA · DevicePhilips North AmericaU.S.Official notice →
  3. 2025-12-10
  4. US
    Drugs & medicalClass II

    Philips North America Llc recalls CT 5300; Software Version Number: 4.5, 5.0, 5.1;

    If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make contact with other components located within the Incisive CT systems…

    FDA · DevicePhilips North America LlcWorldwide distribution - US Nationwide and the countries of Albania, Algeria,…Official notice →
  5. US
    Drugs & medicalClass II

    Philips North America Llc recalls IntelliVue MP90. Product Number: M8010A.

    Potential issue where the IntelliVue monitors did not alarm.

    FDA · DevicePhilips North America LlcWorldwide distribution - US Nationwide and the countries of Afghanistan,…Official notice →
  6. 2025-10-01
  7. US
    Drugs & medicalClass II

    Philips North America Llc recalls Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.

    The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

    FDA · DevicePhilips North America LlcWorldwide distribution - US Nationwide and the countries of Argentina,…Official notice →
  8. 2025-08-06
  9. US
    Drugs & medicalClass II

    Philips North America recalls Ingenia Elition X Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (4) 782136, (5) 782151 (China ONLY);

    The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.

    FDA · DevicePhilips North AmericaWorldwide distribution - US Nationwide and the countries of Albania, Algeria,…Official notice →
  10. 2025-07-02
  11. US
    Drugs & medicalClass II

    Philips North America Llc recalls Spectral CT. Computed tomography X-ray system.

    Devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or patient, along with additional software issues that affect CT…

    FDA · DevicePhilips North America LlcDomestic: AZ, CA, CO, FL, GA, HI, IN, KY, MA, MD, MN, NY, OH, OR, PA, TX, VT,…Official notice →
All 100 Philips recalls →

Other drugs & medical recalls in the United States

  1. 2025-10-22
  2. US
    Drugs & medicalClass II

    Baxter Healthcare Corporation recalls CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL, 92-inch (2.3 meters), Product code 2C8419

    IV sets may leak.

    FDA · DeviceBaxter Healthcare CorporationUS Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO,…Official notice →
  3. US
    Drugs & medicalClass II

    American Contract Systems Inc. recalls Medical convenience kits Item Number/Description HSAN63N ANGIO PACK IHAN02W ANGIOGRAPHY PACK MHCA98AK CORONARY ANGIO PACK- 205991…

    Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to…

    FDA · DeviceAmerican Contract Systems Inc.US Nationwide distribution in the states of SD, IA, MN, WA, IL.Official notice →
  4. US
    Drugs & medicalClass II

    Spacelabs Healthcare, Inc. recalls Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0893-01 Software…

    Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient's safety by interfering with the operation of…

    FDA · DeviceSpacelabs Healthcare, Inc.Worldwide - United States Nationwide distribution including in the states of…Official notice →
  5. US
    Drugs & medicalClass II

    ConvaTec, Inc recalls DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed for use on dry to lightly exudating wounds.…

    Wound dressing may have foreign matter on the product.

    FDA · DeviceConvaTec, IncUS Nationwide distribution including in the states of OH, AL, AZ, CA, CO, FL,…Official notice →
  6. US
    Drugs & medicalClass II

    Fisher & Paykel Healthcare, Ltd. recalls Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723

    When unintentionally disconnected from power source, humidifier device (used to deliver high flow warmed and humidified respiratory gases) may sound audible alert for less than 120 seconds, which may delay user…

    FDA · DeviceFisher & Paykel Healthcare, Ltd.US Nationwide distribution including in the states of TX, MS, LA, NC, TN, NY,…Official notice →
  7. US
    Drugs & medicalClass II

    GE Medical Systems, LLC recalls LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535

    The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impacting overall care.

    FDA · DeviceGE Medical Systems, LLCUS Nationwide. Global Distribution.Official notice →
See all drugs & medical recalls →