The Recall Desk

FDA (Devices) recall action 86025

Philips North America, LLC recalled 3 products on 2020-08-26

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2020-08-26
Critical
0
Units
34,368

Why these products were recalled

A problem has been detected with the Philips LI-Polymer rechargeable battery when used with its approved charging station and module charger. When the battery is inserted into a charger bay, the LED indicatory lights solid red and the battery will not charge. This may result from poor electrical contact between the battery and charger.

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

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–3 of 3

  • ModerateFDA (Devices)··2020-08-26

    Philips MRI Patient Monitoring System Battery Recall for Charging Failure

    Philips is recalling 24,545 rechargeable Li-Polymer batteries used in the Expression MR400 MRI Patient Monitoring System. The batteries may fail to charge due to poor electrical contact.

    Product
    Phillips 3.7V Rechargeable Li-Polymer Battery, Product #: 989803191341 - Product Usage: This battery is used in the Expression MR400 MRI Patient Monitoring System (Model MR400) is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for sy
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2020-08-26

    Philips Module Charger Recall for MRI Patient Monitoring System

    Philips is recalling Module Chargers used in the Expression MR400 MRI Patient Monitoring System because poor electrical contact prevents the lithium-polymer battery from charging.

    Product
    Phillips Module Charger, Product #: 989803191031 - Product Usage: This Module Charger is used in the Expression MR400 MRI Patient Monitoring System (Model MR400) is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization f
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2020-08-26

    Philips Charging Station Recalled Due to Battery Charging Failure

    Philips is recalling charging stations for the Expression MR400 MRI system because the battery fails to charge due to poor electrical contact.

    Product
    Phillips Charging Station, Product #: 989803191021 - Product Usage: This charging station is used in the Expression MR400 MRI Patient Monitoring System (Model MR400) is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronizati
    Category
    Distribution
    0 states