Drugs & medicalClass II

Philips North America recalls Philips PIC iX Essentials REF:867093

Due to software malfunction, patient information system may freeze and become unresponsive.

Read the official notice →
Date
2026-09-23
Country
United States
Brand
Philips
Product
Philips PIC iX Essentials REF:867093
Classification
Class II
Units
Worldwide - US Nationwide distribution including in the states and territories…
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 Details may be shortened or out of date; the official notice is the authoritative source.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. 2026-10-07
  2. US
    Drugs & medicalClass II

    Philips North America recalls Ingenia 3.0T and 3.0T CX; Model number (REF): 1. 781342 (3.0T), 2. 781377 (3.0T), 3. 782103 (3.0T), 4. 781271 (3.0T CX); Software…

    When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction…

    FDA · DevicePhilips North AmericaWorldwide distribution - Nationwide and the countries of Algeria, Argentina,…Official notice →
  3. US
    Drugs & medicalClass II

    Philips North America Llc recalls Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333

    The Bolus tracking scan application may crash with a system error message. Bolus Tracker shots may continue to occur even if the contrast threshold is reached. This may result in the patient receiving additional…

    FDA · DevicePhilips North America LlcU.S. and U.S. Territories.Official notice →
  4. 2026-09-30
  5. US
    Drugs & medicalClass II

    Philips North America Llc recalls Achieva 3.0T; Model Numbers (REF): 1. 781177, 2. 781277, 3. 781278, 4. 781344, 5. 781345;

    A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.

    FDA · DevicePhilips North America LlcWorldwide distribution - US Nationwide and the countries of Albania, Algeria,…Official notice →
  6. 2026-09-09
  7. US
    Drugs & medicalClass II

    Philips North America Llc recalls Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades Product Code: 728232. Software…

    Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.

    FDA · DevicePhilips North America LlcUS and US Territories.Official notice →
  8. 2026-08-26
  9. US
    Drugs & medicalClass II

    Philips North America Llc recalls Cardiac Workstation 5000. Product Number: 860439.

    Device will intermittently provide inaccurate data related to native heart rate.

    FDA · DevicePhilips North America LlcWorldwide distribution - US Nationwide and the countries of Australia,…Official notice →
  10. 2026-07-01
  11. US
    Drugs & medicalClass II

    Philips North America Llc recalls Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following system descriptions: TELE Monitor 5500, 1.4 Ghz,…

    Potential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device configuration and the equipment label, resulting in a failure to reconnect to the PIC iX central monitoring system.

    FDA · DevicePhilips North America LlcUS Nationwide distribution in the states of AZ, CA, CO, IN, MA, MI, MN, PA,…Official notice →
All 100 Philips recalls →

Other drugs & medical recalls in the United States

  1. 2026-09-23
  2. US
    Drugs & medicalClass II

    Bayer Medical Care, Inc. recalls MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT;

    Some devices may not have been properly sterilized due to a manufacturing sterilization issue.

    FDA · DeviceBayer Medical Care, Inc.US Nationwide distribution.Official notice →
  3. US
    Drugs & medicalClass II

    Maquet Cardiopulmonary Gmbh recalls Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 (USA), 701047384 (OUS);

    The packaging may not consistently maintain sterile barrier integrity.

    FDA · DeviceMaquet Cardiopulmonary GmbhWorldwide distribution - US Nationwide and the countries of Australia,…Official notice →
  4. US
    Drugs & medicalClass II

    GE Medical Systems Information Technologies Inc recalls Carescape Central Station CSCS V3 MAS800 Desktop Part Number 5867474-04, 5867474-13 Product code STU CSCS V3…

    Device may not resume patient monitoring for at least 3 minutes following system restart. Issue can lead to potential delay in recognition of clinically significant events.

    FDA · DeviceGE Medical Systems Information Technologies IncWorldwide - US Nationwide distribution.Official notice →
  5. US
    Drugs & medicalClass II

    Medline Industries, LP recalls Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N

    The kits contain a Retrograde Coronary Sinus Perfusion (RCSP) cannulae that has the potential for a sterile barrier breach. Sterility of the product cannot be assured. If a compromised pouch seal is not identified…

    FDA · DeviceMedline Industries, LPUS Nationwide distribution in the state of CA.Official notice →
  6. US
    Drugs & medicalClass I

    Nova Biomedical Corporation recalls StatStrip Glucose and B- Ketone meter. Model No: 63910. Glucose test system.

    A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient identification (ID)…

    FDA · DeviceNova Biomedical CorporationWorldwide distribution: US (nationwide) and OUS (foreign) countries of:…Official notice →
  7. US
    Drugs & medicalClass I

    Medline Industries, LP recalls Medline Convenience Kits: 1) DYKM1000B, Catalog Number: DYKM1000B; 2) DYKM2187A, Catalog Number: DYKM2187A

    The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of…

    FDA · DeviceMedline Industries, LPUS Nationwide distribution.Official notice →
See all drugs & medical recalls →