Drugs & medicalClass II

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labeled as the following with corresponding model…

Potential that a component (air baffle) may be missing in some Nehalem FlexVision-2 PCs that are part of the Allura Xper series.

Read the official notice →
Date
2025-09-10
Country
United States
Brand
Philips Medical Systems Nederland
Product
Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labeled as the following with corresponding model numbers: 1.…
Classification
Class II
Units
Worldwide - US Nationwide distribution in the states of AL, AZ, CA, DC, FL,…
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 Details may be shortened or out of date; the official notice is the authoritative source.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 Medical Systems Nederland recalls

  1. 2025-10-08
  2. US
    Drugs & medicalClass II

    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842,…

    The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages…

    FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Albania, Algeria,…Official notice →
  3. 2025-10-01
  4. US
    Drugs & medicalClass II

    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008; Associated 510(k) numbers: K102005, K130842, K130638,…

    Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system…

    FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Albania, Algeria,…Official notice →
  5. 2025-09-17
  6. US
    Drugs & medicalClass II

    Philips Medical Systems Nederland B.V. recalls IntelliSpace Cardiovascular, Software 8.0.0.4.

    Software issue that results in the display of outdated information.

    FDA · DevicePhilips Medical Systems Nederland B.V.US Nationwide distribution in the states of GA, NC & TX.Official notice →
  7. 2025-09-10
  8. US
    Drugs & medicalClass II

    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with…

    Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) have the potential of shutting down and/or not starting up, if power to the system is lost.

    FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Argentina,…Official notice →
  9. 2025-08-06
  10. US
    Drugs & medicalClass II

    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: 722026. 2. Allura Xper…

    Potential for temporary loss of imaging (X-ray) functionality due to software issue.

    FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide - US Nationwide and the countries of Algeria, Argentina, Australia,…Official notice →
  11. 2025-07-30
  12. US
    Drugs & medicalClass II

    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 7 M20. Fluoroscopic X-Ray System.

    Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose.

    FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution: US (nationwide) to states of: CA, CO, DC, DE, FL, IL,…Official notice →
All 59 Philips Medical Systems Nederland recalls →

Other drugs & medical recalls in the United States

  1. 2025-09-10
  2. US
    Drugs & medicalClass II

    Preat Corp recalls NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662

    Engaging titanium base was manufactured 180 degrees around the post from where it should be located in relation to the connection geometry; if the flat is on the wrong side of the post, the crown will not fit onto the…

    FDA · DevicePreat CorpUS Nationwide distribution in the states of NY, FL, PA, CA, OH.Official notice →
  3. US
    Drugs & medicalClass II

    Medshape, INC. recalls Medshape Universal Joints, REF: DNE-9000-UJ

    Bone external fixation system may have the pin that can become dislodged resulting in frame instability, the use of this product may cause a delay in surgery or a revision if the device is use.

    FDA · DeviceMedshape, INC.US Nationwide distribution in the states of CA, IL, NJ, TX, FL, IN, OH, WI,…Official notice →
  4. US
    Drugs & medicalClass II

    Integra LifeSciences Corp. (NeuroSciences) recalls Brand Name: MediHoney ¿ Product Name: MediHoney¿ Paste Model/Catalog Number: 31505 Product Description: MediHoney¿…

    Packaging failures were identified which could lead to a breach in the sterile barrier.

    FDA · DeviceIntegra LifeSciences Corp. (NeuroSciences)Worldwide - US Nationwide distribution including in the states of AK, AL, AR,…Official notice →
  5. US
    Drugs & medicalClass II

    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with…

    Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) have the potential of shutting down and/or not starting up, if power to the system is lost.

    FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Argentina,…Official notice →
  6. US
    Drugs & medicalClass II

    Visgeneer, Inc. recalls Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)

    Due to products distributed without premarket clearance or approvals.

    FDA · DeviceVisgeneer, Inc.Worldwide - U.S. Nationwide distribution in the states of CA and MI. The…Official notice →
  7. US
    Drugs & medicalClass II

    Physio-Control, Inc. recalls LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 LIFEPAK CR2: The LIFEPAK CR2 defibrillator is…

    Due to required inspections not being performed on products/units that have gone through servicing.

    FDA · DevicePhysio-Control, Inc.U.S. Nationwide distribution in the states of CO and MT.Official notice →
See all drugs & medical recalls →