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…

Read the official notice →
Date
2024-02-07
Country
United States
Brand
Philips Medical Systems Nederland
Product
Philips Azurion system, Interventional fluoroscopic x-ray system. System Product Name - Model Numbers Azurion 3M12 -722063, 722221;…
Classification
Class II
Units
Worldwide - US Nationwide distribution.
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 Details may be shortened or out of date; the official notice is the authoritative source.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
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    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 →
  3. 2024-02-07
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    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
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    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.

    FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide - US Nationwide distribution in the states of CO, FL, IL, MS, NV and…Official notice →
  6. 2023-12-27
  7. 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 →
  8. 2023-09-20
  9. 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 →
  10. 2023-09-13
  11. US
    Drugs & medicalClass II

    Philips Medical Systems Nederland B.V. recalls Allura Xper series

    A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation

    FDA · DevicePhilips Medical Systems Nederland B.V.US Nationwide DistributionOfficial notice →
All 59 Philips Medical Systems Nederland recalls →

Other drugs & medical recalls in the United States

  1. 2024-02-07
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    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 →
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    FDA · DeviceFX SHOULDERUS Nationwide distribution in the state of NJ.Official notice →
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    There is the potential for incomplete staple line formation during the firing sequence, without most or all staples, which may lead to insufficient tissue apposition that could require surgical intervention. This may…

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    American Contract Systems, Inc. recalls Procedural convenience kits and trays, cardiac, labeled as: a) EP LAB BI V IMPLANT PACK, kit number AGBI64J; b) LAB DEVICE…

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