The Recall Desk

FDA (Devices) recall action 80402

Philips Healthcare recalled 3 products on 2018-08-01

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
2018-08-01
Critical
0
Units
1,377

Why these products were recalled

The first time an operator selects a new procedure type during a single examination,the shutter position resets to the open position for the new procedure type. If the shutters had previously been changed during the examination, that setting is not retained after the first time the procedure type is changed during a single examination.

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)··2018-08-01

    Philips Healthcare Recalls UNIQ Systems Due to Shutter Position Reset Issue

    Philips Healthcare is recalling 459 UNIQ systems because the shutter position resets to open when a new procedure type is selected, potentially losing previous settings.

    Product
    UNIQ Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive procedures. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA,st
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2018-08-01

    Philips Centron Medical Imaging Systems Recalled for Shutter Reset Issue

    Philips Healthcare is recalling 459 Centron systems because shutter settings reset when procedure types change, potentially affecting imaging accuracy.

    Product
    Centron Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive procedures. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2018-08-01

    Philips Allura Xper Medical Imaging Systems Recalled for Shutter Reset Issue

    Philips Healthcare is recalling 459 Allura Xper systems because shutter positions reset when procedure types change, potentially affecting imaging accuracy.

    Product
    Allura Xper Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive procedures. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as
    Category
    Distribution
    0 states