BEUDAMED
    FDA Recall Open, Classified

    SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits are sold as accessories for the SimplyGo Mini: SimplyGo Mini Portable Oxygen Concentrator Product code: 1113600

    Recall: Z-0481-2026 · Initiated October 7, 2025

    Recall

    Recall Number
    Z-0481-2026
    Event Number
    97736
    Firm
    Philips Respironics, Inc.
    FEI Number
    2518422
    Product Code
    CAW
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 7, 2025
    Posted
    November 7, 2025
    Address
    1001 Murry Ridge Ln, Murrysville, PA, 15668-8517

    Description

    SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits are sold as accessories for the SimplyGo Mini: SimplyGo Mini Portable Oxygen Concentrator Product code: 1113600

    Reason

    Certain serial numbers of the SimplyGo Mini standard battery kit contain a defective chip which can lead the battery to either fail to charge or lose voltage output when in use in the device. If the fault occurs while the device is running on battery power, the SimplyGo Mini will shut down and stop providing oxygen to the user. This may happen at a temperature within the specified operating temperature range of the SimplyGo Mini.

    Action

    On October 7, 2025 URGENT MEDICAL DEVICE RECALL letters were sent to customers. Actions for Distributors: Check inventory and place into quarantine any identified affected products. Complete and return the provided response form. Alert any customers who may have purchased affected products and work with them to return the affected product. A Philips representative will reach out regarding return and replacement of all affected product. Actions for patients: Check the serial numbers to verify if product affected by recall. If your product is affected, please discontinue use or the battery immediately. Contact your distributor and follow their instructions on how to receive a replacement battery and arrange for the return of the affected batteries in your possession. If the serial number on your battery kit does not match any of the affected serial numbers, then your battery is not affected by this issue and there is no need for any further action by you.

    Distribution

    US Nationwide distribution in the states of GA, ID, KY, NJ, NY and the country of Canada.

    Quantity

    56 units (55 US, 1 OUS)