Drugs & medicalClass II

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)

Loss of connectivity between the FlexArm and the Table due to a software issue.

Read the official notice →
Date
2024-02-07
Country
United States
Brand
Philips Medical Systems Nederland
Product
Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)
Classification
Class II
Units
Worldwide - US Nationwide distribution in the states of CO, FL, IL, MS, NV and…
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 Details may be shortened or out of date; the official notice is the authoritative source.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. 2024-02-28
  2. US
    Drugs & medicalClass II

    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected…

    Disk Bay may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure.

    FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide Distribution: US nationwide including states of: AL, AK, AR, AZ, CA,…Official notice →
  3. US
    Drugs & medicalClass II

    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected…

    Framegrabber card may not perform as intended. Monitor may show no viewports, or show one or more viewports may show no image, a distorted image, or a frozen image. Switching between viewports on the monitor may not be…

    FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide - US Nationwide distribution.Official notice →
  4. 2024-02-07
  5. US
    Drugs & medicalClass II

    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)

    Loss of connectivity between the FlexArm and the Table due to a software issue related to the date/time format. This connection issue leads to a loss of movement of the arm or table.

    FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide - US Nationwide distribution in the states of CO, FL, IL, MS, NV and…Official notice →
  6. US
    Drugs & medicalClass II

    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion system, Interventional fluoroscopic x-ray system. System Product Name - Model Numbers Azurion 3M12…

    System may exhibit a loss of imaging functionality and data due to an issue which can cause the system to continuously restart. If the issue occurs during a procedure, there may be a delay and/or abortion of the…

    FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide - US Nationwide distribution.Official notice →
  7. 2023-12-27
  8. US
    Drugs & medicalClass II

    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion systems with monoplane fixed ceiling mounts: 722078 Azurion 7 M12 722079 Azurion 7 M20 722223 Azurion 7…

    Ceiling mounted L-arm contains a rotation cover that may potentially be susceptible to falling if a collision between the L-arm and other hospital equipment (i.e., an operating light) were to occur result in injury or…

    FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide - US Nationwide and the countries of Albania, Algeria, Argentina,…Official notice →
  9. 2023-09-20
  10. US
    Drugs & medicalClass II

    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systems

    A damaged foot switch may cause instances where no or only intermittent x-ray radiation initiation is possible.

    FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distributionOfficial notice →
All 59 Philips Medical Systems Nederland recalls →

Other drugs & medical recalls in the United States

  1. 2024-02-07
  2. US
    Drugs & medicalClass I

    Smiths Medical ASD Inc. recalls smiths medical Medfusion Model 4000 syringe pump

    Medfusion Model 4000 syringe infusion pumps, with the following software versions, may have the following issues: 1. Delivery During Motor Not Running High Priority Alarm (v1.0.0, v1.1.0, v1.1.1, v1.1.2), 2.…

    FDA · DeviceSmiths Medical ASD Inc.US nationwide, Canada, Great Britain, Bermuda, Australia, Germany, Singapore,…Official notice →
  3. US
    Drugs & medicalClass I

    Smiths Medical ASD Inc. recalls smiths medical Medfusion Model 3500 Syringe pump

    Medfusion syringe pumps, with software versions before v6.0.0, may have the following issues:1. Delivery During Motor Not Running High Priority Alarm, 2. Infusion Restarted with Incorrect Parameters, 3. Screen Lock, 4.…

    FDA · DeviceSmiths Medical ASD Inc.worldwideOfficial notice →
  4. US
    Drugs & medicalClass II

    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)

    Loss of connectivity between the FlexArm and the Table due to a software issue related to the date/time format. This connection issue leads to a loss of movement of the arm or table.

    FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide - US Nationwide distribution in the states of CO, FL, IL, MS, NV and…Official notice →
  5. US
    Drugs & medicalClass II

    XTANT Medical Holdings, Inc recalls Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.

    Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length were manufactured using an incorrect screw shank component, and so the labeling is incorrect because the affected screws are in fact 5.5 diameter, 45 mm…

    FDA · DeviceXTANT Medical Holdings, IncUS distribution in MI.Official notice →
  6. US
    Drugs & medicalClass II

    Covidien LP recalls Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0…

    Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could result in harms such as wound…

    FDA · DeviceCovidien LPWorldwide US Nationwide distribution including in the states of AL, AZ, CA,…Official notice →
  7. US
    Drugs & medicalClass II

    FX SHOULDER recalls Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210

    Centered glenosphere box may contain an eccentric glenosphere.

    FDA · DeviceFX SHOULDERUS Nationwide distribution in the state of NJ.Official notice →
See all drugs & medical recalls →