The Recall Desk

FDA (Devices) recall action 75845

Philips Electronics North America Corporation recalled 4 products on 2017-02-01

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2017-02-01
Critical
0
Units
6

Why these products were recalled

Due to a production error, screws were not tightened to specified torque. These screws may come loose from the C-arm shaft causing the C-arm to rotate uncontrolled.

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

1–4 of 4

  • SevereFDA (Devices)··2017-02-01

    Philips Allura Xper FD10 X-ray System Recalled for Loose Screws

    Philips is recalling one Allura Xper FD10 X-ray system because production errors left screws loose, potentially causing the C-arm to rotate uncontrolled.

    Product
    Allura Xper FD10 722026 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electro Physiology(EP).
    Category
    Distribution
    1 state
  • SevereFDA (Devices)··2017-02-01

    Philips Allura Xper FD20/15 C-arm Recall Due to Loose Screws

    Philips is recalling two Allura Xper FD20/15 systems because production errors may cause C-arm screws to loosen, leading to uncontrolled rotation.

    Product
    Allura Xper FD20/15 R8.2 722058 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electro Physiology(EP).
    Category
    Distribution
    1 state
  • SevereFDA (Devices)··2017-02-01

    Philips Allura Xper FD20 C-arm Recall Due to Loose Screws

    Philips is recalling two Allura Xper FD20 C-arm systems because production errors left screws loose, posing a risk of uncontrolled rotation.

    Product
    Allura Xper FD20 R8.2 722028 is 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
  • SevereFDA (Devices)··2017-02-01

    Philips Allura Xper FD20 C-arm Recall for Loose Screws

    Philips is recalling one Allura Xper FD20 unit because production errors left screws loose, which could cause the C-arm to rotate uncontrolled.

    Product
    Allura Xper FD20 722012 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electro Physiology(EP).
    Category
    Distribution
    1 state