BEUDAMED
    FDA Recall Terminated

    Philips SureSigns VM4, VM6 and VM8 - Product Usage: patient monitors-for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. (CHINA only) SureSigns VM4 (863063, 863085) SureSigns VM6 (863064, 863065, 863086) SureSi"gns VM8 (863066, 863068, 863087, 863088) Model Numbers: 863063,863064,863065,863066,863068,863085,863086, 453564021961,453564021971, 53564022001,453564022041, 53564022081,453564024371, 453564024401,453564024421 453564024441,453564024461, 453564024481

    Recall: Z-1326-2021 · Initiated March 23, 2021

    Recall

    Recall Number
    Z-1326-2021
    Event Number
    87418
    Firm
    Philips North America, LLC
    FEI Number
    1218950
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 23, 2021
    Terminated
    September 28, 2023
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032

    Description

    Philips SureSigns VM4, VM6 and VM8 - Product Usage: patient monitors-for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. (CHINA only) SureSigns VM4 (863063, 863085) SureSigns VM6 (863064, 863065, 863086) SureSi"gns VM8 (863066, 863068, 863087, 863088) Model Numbers: 863063,863064,863065,863066,863068,863085,863086, 453564021961,453564021971, 53564022001,453564022041, 53564022081,453564024371, 453564024401,453564024421 453564024441,453564024461, 453564024481

    Reason

    Fail to Comply with Chinese Standard YY1079-2008: Clauses 4.2.6 and 4.2.7.3. Range/accuracy of heart rate meter for pediatric mode-In pediatric mode, when the input signal rate is over 300 bpm, the indicated rate of the affected products will be lower than this upper limit

    Action

    Philips Market Organizations are responsible for distributing the letters outside of the U.S. Letter issued on 3/23/21 , stating: Reason for correction, health risk and Action to be Taken by Customer/User states: This issue only happens on pediatric type patient with heartrate is greater than device claimed maximum heart rate 300 bpm. The device can continue to be used, however when using the monitor in the Pediatric category, patients at risk for tachycardia should be kept under close observation in accordance with existing product warnings described in the IFU. You may also consider to keep the default HR alarm limits or set tight HR alarm limits around the patients baseline HR for these patients Philip will send an engineer onsite to check the SW revision of your monitors. PHILIPS Subsequently a SW upgrade will be performed if your device is with the affected software revision. A Philips Healthcare representative will contact you to arrange for the correction.

    Distribution

    International distribution in the country of China.

    Quantity

    31773 units