Recall Atlas
Drugs & medicalClass II

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion 5 M12. Model Number: 722227.

Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced reliability over…

Read the official notice →
Date
2026-11-04
Country
United States
Brand
Philips Medical Systems Nederland
Product
Philips Azurion 5 M12. Model Number: 722227.
Classification
Class II
Units
Worldwide distribution - US Nationwide and the countries of Afghanistan,…
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 Details may be shortened or out of date; the official notice is the authoritative source.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. 2026-08-19
  2. Drugs & medicalClass II

    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software Version…

    Two software related issues: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead…

    FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution.Official notice →
  3. Drugs & medicalClass II

    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224,…

    Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of…

    FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.WorldwideOfficial notice →
  4. Drugs & medicalClass II

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    Firmware issue potentially leading to loss of geometry movements.

    FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Canada, Algeria,…Official notice →
  5. 2026-08-12
  6. Drugs & medicalClass II

    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interventional Fluoroscopic X-Ray System.

    Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.

    FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.US Nationwide distribution.Official notice →
  7. 2026-06-24
  8. Drugs & medicalClass II

    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 for MultiDiagnost Eleva; Model # 708034 for…

    Philips Allura Xper and MultiDiagnost-Eleva systems Hand switch button not fully releasing potentially leading to loss of imaging functionality or unintended radiation exposure and additional contrast injection

    FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.US and ROW.Official notice →
  9. 2026-06-10
  10. Drugs & medicalClass II

    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with…

    During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without…

    FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.US Nationwide distribution.Official notice →
All 60 Philips Medical Systems Nederland recalls →

Other drugs & medical recalls in the United States

  1. 2026-11-04
  2. Drugs & medicalClass II

    Pentax of America Inc recalls PENTAX Medical Ultrasound Endoscope. Model Numbers. EG-3870UTK, EG-3670URK.

    Warnings added to the IFU for ultrasound endoscopes and water bottle assembly to ensure there is deaerated sterile water in the assembly prior to and during the procedure.

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  3. Drugs & medicalClass II

    Medtronic, Inc. recalls CareLink SmartSync Programmer, Model 24970A, Pulse generator, permanent, implantable

    Software problem has the potential for an inaccurate displayed longevity estimate.

    FDA · DeviceMedtronic, Inc.Worldwide distribution.Official notice →
  4. Drugs & medicalClass II

    BioMerieux SA recalls EMAG system Model/Catalog Number: 418591/418591U Product Description: Nucleic acid sample preparation instrument IVD, automated

    Delayed or no result when analyzing clinical samples with EMAG system (ref: 418591/418591U) due to a randomly occurring software error, Error 10003 Heater timeout after updating to recent firmware SP4 Patch 2

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  5. Drugs & medicalClass II

    Canon Medical System, USA, INC. recalls ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM REF: INFX-8000F

    Due to software issue, X-ray interventional system may experience internal error if F-Store or imagine acquisition is performed while clinical analysis function is use.

    FDA · DeviceCanon Medical System, USA, INC.US Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, HI, IL,…Official notice →
  6. Drugs & medicalClass II

    Philips North America recalls Model Number: 712010.

    Potential for the device to fail immediately after an exposure, causing the system to remain stationary.

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  7. Drugs & medicalClass II

    ZIEHM-ORTHOSCAN INC recalls Orthoscan VERSA Accessory Cart, REF: 1000-0021 and Versa Mini C-Arm System, REF: 1000-0020

    The accessory cart weldment does not conform to weld dimensional specifications which may result in separation of the monitor arm mounting structure from the cart.

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See all drugs & medical recalls →