Drugs & medicalClass II

Philips North America Llc recalls Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the fetal heart and externally monitors fetal heart rate.

Potential for inaccurate fetal heart rate measurements when monitoring multiples.

Read the official notice →
Date
2024-07-10
Country
United States
Brand
Philips
Product
Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the fetal heart and externally monitors fetal heart rate.
Classification
Class II
Units
Worldwide distribution - US Nationwide and the countries of AD, AE, AR, AT,…
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 Details may be shortened or out of date; the official notice is the authoritative source.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. 2024-10-02
  2. US
    Drugs & medicalClass II

    Philips North America recalls IntelliVue Patient Monitor MX400 (Model Number 866060), MX430 (Model Number 866061), MX450 (Model Number 866062), MX500 (Model Number…

    During a production process, Philips became aware of one IntelliVue power supply with a broken ground bolt upon disconnection of the ground cable from the equipotential ground connector. Loss of electrical grounding…

    FDA · DevicePhilips North AmericaUS Nationwide. Global Distribution.Official notice →
  3. US
    Drugs & medicalClass II

    Philips North America Llc recalls Ingenia 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal…

    Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the horizontal tabletop. May…

    FDA · DevicePhilips North America LlcWorldwide distribution - US Nationwide and the countries of Argentina,…Official notice →
  4. 2024-08-14
  5. US
    Drugs & medicalClass II

    Philips North America Llc recalls IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866064. Indicated for use by health…

    Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software Options. Changes were made to reflect some options becoming standard capabilities for software-version N.x. In the…

    FDA · DevicePhilips North America LlcNationwide Foreign: Australia Austria Bangladesh Brazil Canada Chile China…Official notice →
  6. 2024-07-03
  7. US
    Drugs & medicalClass I

    Philips North America Llc recalls SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model…

    Potential for coils to heat up and harm patients (burn).

    FDA · DevicePhilips North America LlcWorldwide distribution: US (Nationwide) and OUS (Foreign): Afghanistan,…Official notice →
  8. 2024-06-12
  9. US
    Drugs & medicalClass II

    Philips North America Llc recalls HA FlexTrak II-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number:…

    Oil may leak from the HA FlexTrack Trolley onto the floor when pressing the hydraulic pedal, resulting in a potential slipping/falling hazard

    FDA · DevicePhilips North America LlcWorldwide distribution - US Nationwide and the countries of Australia,…Official notice →
  10. 2024-05-29
  11. US
    Drugs & medicalClass II

    Philips North America Llc recalls Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728144

    Metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive CT system, may become compromised, resulting in potential contact with other gantry components located within the…

    FDA · DevicePhilips North America LlcWorldwide - US Nationwide distribution.Official notice →
All 100 Philips recalls →

Other drugs & medical recalls in the United States

  1. 2024-07-10
  2. US
    Drugs & medicalClass II

    MicroPort Orthopedics Inc. recalls EVOLUTION¿ MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee replacement implants are for cemented use only.

    One confirmed incident has been received that EFSRN4PR, lot number MP1982170, Size 4 Evolution MP Non-Porous Femoral Right was opened during surgery and contained part number EFSRN3PL, lot number MP1982097, Size 3…

    FDA · DeviceMicroPort Orthopedics Inc.International distribution in the country of China. There is no field…Official notice →
  3. US
    Drugs & medicalClass II

    WOM World Of Medicine AG recalls WOM Tube Set for lrrlgatlon, single-use- Intended to transport irrigation fluid to the patient in endoscopic surgeries. Distr. by…

    Incorrect transponder data was written on the RFID tags triggers the error message E03, Tube Set lnvalid, may result in a delay of surgery

    FDA · DeviceWOM World Of Medicine AGUS Nationwide distribution.Official notice →
  4. US
    Drugs & medicalClass II

    Siemens AG/Siemens Healthcare GmbH recalls ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional…

    A potential issue with ARTIS icono systems equipped with a small detector and a corresponding collimator (model # 10843101) was identified. In very rare situations, the first x-ray release following patient…

    FDA · DeviceSiemens AG/Siemens Healthcare GmbHWorldwide - US Nationwide distribution in the states of TX, MA, NH, MN, OK,…Official notice →
  5. US
    Drugs & medicalClass II

    Applied Medical Technology Inc recalls AMT Initial Placement Dilator Set. Used to place gastrostomy devices.

    Devices were labelled with the incorrect guidewire labelling.

    FDA · DeviceApplied Medical Technology IncUS Nationwide distribution in the states of GA, IL, IN, LA, NC, NE, SC, TN,…Official notice →
  6. US
    Drugs & medicalClass II

    Beckman Coulter, Inc. recalls Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometric chemistry analyzer for clinical use. It is an in-vitro…

    The reason for the recall is the pneumatic tubing used in the analytical pick-and-place (PnP) assembly cable may fully or partially disconnect from the flex cable assembly fittings during normal operation. The DxI 9000…

    FDA · DeviceBeckman Coulter, Inc.Worldwide - US Nationwide distribution in the state of Indiana and the…Official notice →
  7. US
    Drugs & medicalClass II

    Exactech, Inc. recalls Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b) 100-22-20, SZ. M; c) 100-22-21,…

    The AcuMatch L-Series 22mm Inner Diameter Bipolar Hip Liner lots were packaged without the specified ethylene vinyl alcohol (EVOH) layer. Between 2004 and August 2021, our packaging process utilized two different types…

    FDA · DeviceExactech, Inc.Worldwide - US distribution in Puerto Rico and the countries of Great Britain,…Official notice →
See all drugs & medical recalls →