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Medical Device Recalls | FDA

    https://www.fda.gov/medical-devices/medical-device-safety/medical-device-recalls
    The FDA posts summaries of information about the most serious medical device recalls. These products are on the list because there is a reasonable chance that they could cause serious health...

2022 Medical Device Recalls | FDA

    https://www.fda.gov/medical-devices/medical-device-recalls/2022-medical-device-recalls
    11/01/22. Philips Respironics Recalls Certain Masks for BiPAP, CPAP Machines Due to Safety Issue with Magnets That May Affect Certain Medical Devices. 10/18/22. Jiangsu …

Philips Issues a Recall Notification* to Mitigate Potential …

    https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/philips-issues-recall-notification-mitigate-potential-health-risks-related-sound-abatement-foam
    Therefore, the full year comparable sales growth and Adjusted EBITA margin guidance provided on April 26, 2021 remains unchanged. The updated …

Durable Medical Equipment (DME) Center | CMS

    https://www.cms.gov/Center/Provider-Type/Durable-Medical-Equipment-DME-Center
    The Centers for Medicare & Medicaid Services (CMS) recently issued a final rule that takes effect on February 28, 2022 and classifies non-implantable continuous glucose …

Understanding the recall process | Philips

    https://www.usa.philips.com/healthcare/e/sleep/communications/src-update/news/understanding-the-recall-process
    Understand how we’re handling the recall and know what to expect. We understand that waiting for news about when and how your device will be repaired or replaced can be …

MLN905709 – DMEPOS Quality Standards - Centers for …

    https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/DMEPOSQuality/DMEPOSQualBooklet-905709.html
    Data collection may target services that could cause harm or injury, occur frequently (creating more adjustments, repairs, or replacements than expected), or require …

NCD - Durable Medical Equipment Reference List (280.1)

    https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?&NCDId=190&NCDSect=280.1
    The durable medical equipment (DME) list that follows is designed to facilitate the Medicare Administratinve Contractor’s (MAC's) processing of DME …

Recalls | CPSC.gov - U.S. Consumer Product Safety …

    https://www.cpsc.gov/Recalls
    BRP Recalls Side-By-Side Vehicles Due to Fire Hazard (Recall Alert) Hazard: The recalled vehicles can have a defective fuel hose assembly which could lead …

DMEPOS Templates | CMS

    https://www.cms.gov/Research-Statistics-Data-and-Systems/Computer-Data-and-Systems/Electronic-Clinical-Templates/DMEPOS-Templates/DMEPOS-Templates
    DMEPOS Templates Templates and Suggested Clinical Data Elements (CDEs) for Durable Medical Equipment, Prosthetics, Orthotics & Supplies (DMEPOS) …

Complaints about durable medical equipment (DME)

    https://www.medicare.gov/claims-appeals/file-a-complaint-grievance/complaints-about-durable-medical-equipment-dme
    To file a complaint about DME, you can: Contact your supplier. Call us at 1-800-MEDICARE (1-800-633-4227). TTY users can call 1-877-486-2048. If you got a competitively bid item …



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