The Recall Desk

FDA (Devices) recall action 68311

Philips Medical Systems, Inc. recalled 2 products on 2014-06-25

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2014-06-25
Critical
0
Units
425

Why these products were recalled

Ingenia customers have experienced clamping of the foot under the central column of the Height Adjustable Flex Trak trolley and the Trolley Variable Height IRF.

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.

1–2 of 2

  • HighFDA (Devices)··2014-06-25

    Philips MR Trolley Recall for Foot Clamping Hazard

    Philips is recalling Height Adjustable FlexTrak trolleys and Trolley Variable Height IRFs for Ingenia MR systems due to a risk of foot clamping.

    Product
    Philips MR systems: Trolley Variable Height IRF (for Ingenia 1.5T & 3.0T products) Product Usage: Diagnostic MR System. The Height Adjustable FlexTrak trolley and Trolley Variable Height IRF is an optional device designed to prepare the patient outside the examination room…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-06-25

    Philips Ingenia FlexTrak Trolley Recalled for Foot Clamping Hazard

    Philips is recalling Ingenia HA FLEX TRAK Trolleys because the central column can clamp a patient's foot. The recall covers 420 units distributed worldwide.

    Product
    Philips MR systems: Ingenia HA FLEX TRAK Trolley (for Ingenia 1.5T & 3.0T products) Product Usage: Diagnostic MR System. The Height Adjustable FlexTrak trolley and Trolley Variable Height IRF is an optional device designed to prepare the patient outside the examination room…
    Category
    Distribution
    0 states