The Recall Desk

FDA (Devices) recall action 80645

Philips Electronics North America Corporation recalled 5 products on 2018-08-29

The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.

Products
5
Announced
2018-08-29
Critical
0
Units
—

Why these products were recalled

Philips has received several reports in which monitors with lithium ion batteries that had exceeded their battery life expectancy have overheated or ignited. These batteries should be replaced every 3 years or upon reaching 300 charge-discharge cycles. Although the Philips SureSigns VS & VM Monitors and View Station (VSV) can display actual information on either or both battery age and charge-discharge cycles, the existing labeling does not include full instructions on how to use this information to determine when to replace the battery. An overheated battery may in turn cause the device cas…

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–5 of 5

  • SevereFDA (Devices)··2018-08-29

    Philips SureSigns VS4 Vital Signs Monitor Recalled for Battery Fire Risk

    Philips is recalling SureSigns VS4 monitors because lithium-ion batteries may overheat or ignite if not replaced on time, posing injury and property damage risks.

    Product
    Philips SureSigns VS4 Vital Signs Monitor, 863283 863286 The SureSigns VS4 vital signs monitor is for use by healthcare professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSigns VS4 monitor is for monitoring, recording, and
    Category
    Distribution
    1 state
  • SevereFDA (Devices)··2018-08-29

    Philips SureSigns VSV Monitors Recalled for Battery Overheating and Ignition Risk

    Philips is recalling SureSigns VSV monitors because lithium-ion batteries may overheat or ignite if not replaced on schedule, posing fire and injury risks.

    Product
    Philips SureSigns VSV (Vital Signs Viewer), 863067 Indicated for central monitoring of multiple adult, pediatric and neonatal patients, and where the clinician decides to monitor cardiac arrhythmia of adult, pediatric and neonatal patients to gain information for the treatment
    Category
    Distribution
    1 state
  • SevereFDA (Devices)··2018-08-29

    Philips SureSigns VS3 Vital Signs Monitor Recall for Battery Fire Risk

    Philips is recalling SureSigns VS3 monitors because lithium-ion batteries may overheat or ignite if not replaced on time, posing fire and injury risks.

    Product
    Philips SureSigns VS3 Vital Signs Monitor, 863069 863070 863071 863072 863073 863074 The SureSigns VS3 monitor is for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the
    Category
    Distribution
    1 state
  • SevereFDA (Devices)··2018-08-29

    Philips SureSigns Patient Monitors Recalled for Battery Overheating and Ignition Risk

    Philips is recalling SureSigns VM, VS, and VSV patient monitors because lithium-ion batteries may overheat or ignite if not replaced on time, posing injury and property damage risks.

    Product
    Philips SureSigns VM 3/4/6/8 Patient Monitors, 863063 863064 863065 863066 863068 863077 863085 863086 863317 863287 863288 863289 The SureSigns VM4, VM6, and VM8 patient monitors are for use by health care professionals whenever there is a need for monitoring the
    Category
    Distribution
    1 state
  • SevereFDA (Devices)··2018-08-29

    Philips SureSigns VS2 Monitor Recall for Battery Overheating and Ignition Risk

    Philips is recalling SureSigns VS2 monitors because lithium-ion batteries may overheat or ignite if not replaced on time, posing fire and injury risks.

    Product
    Philips SureSigns VS2 monitor, 863079 863080 863081 863082 863283 863286 The Sure Signs VS2 vital signs monitor is for use by healthcare professionals whenever there is a need for monitoring the physiological parameter of patients. Standard and optional parameters includ
    Category
    Distribution
    1 state