The Recall Desk

FDA (Devices) recall action 72599

Philips Electronics North America Corporation recalled 29 products on 2016-02-10

The FDA (Devices) publishes a recall like this one as 29 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 29 pages.

Products
29
Announced
2016-02-10
Critical
0
Units
385,613

Why these products were recalled

The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.

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.

States named across these recalls

26–29 of 29

  • HighFDA (Devices)··2016-02-10

    Philips Allura Xper X-ray Systems Recalled for Image Display Error

    Philips is recalling Allura Xper FD10/10 systems because a software issue may cause still images to be mistaken for live images during X-ray procedures.

    Product
    Allura Xper FD10/10; Model Numbers: 722027 722011 722005 Intended for Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and ElectroPhysiology (EP).
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2016-02-10

    Philips Allura Xper FD20/10 Recalled for Image Display Error

    Philips is recalling 13,297 Allura Xper FD20/10 systems because a software error may cause still images to be interpreted as live images.

    Product
    Allura Xper FD20/10; Model Numbers: 722029 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements, embolisat
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2016-02-10

    Philips Allura Xper OR Table Recall for Image Interpretation Error

    Philips is recalling Allura Xper FD10 OR Tables because still images may be misinterpreted as live images during cardiovascular procedures.

    Product
    Allura Xper FD10 OR Table; Model Numbers: 722033 722022 Intended for Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and ElectroPhysiology (EP).
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2016-02-10

    Philips INTEGRIS and Allura Systems Recalled for Image Display Error

    Philips is recalling INTEGRIS and Allura systems because a software issue may cause still images to be misinterpreted as live images.

    Product
    INTEGRIS H3000; Model Number: 72238 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional
    Category
    Distribution
    1 state