The Recall Desk

FDA (Devices) recall action 68723

Philips Medical Systems, Inc. recalled 2 products on 2014-11-19

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
2014-11-19
Critical
0
Units
24

Why these products were recalled

Faulty Automatic Motion Controller (AMC), a problem in the Power On Self Test (POST) error handling was detected, can result in a hazardous movement of the C-arc. system.

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

1–2 of 2

  • SevereFDA (Devices)··2014-11-19

    Philips Allura Xper FD20C Recalled for Faulty Motion Controller

    Philips Medical Systems is recalling two Allura Xper FD20C systems due to a faulty Automatic Motion Controller that may cause hazardous C-arc movement.

    Product
    Philips Medical Systems Allura Xper FD20C with software version R8.2.O System Code: 722035. The Allura Xper FD series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-11-19

    Philips Allura Xper FD20C Radiological Imaging Systems Recalled for Motion Controller Fault

    Philips is recalling 22 Allura Xper FD20C radiological imaging systems due to a faulty Automatic Motion Controller that may cause hazardous movement of the C-arc.

    Product
    Philips Medical Systems Allura Xper FD20C Radiological Imaging with software version R8.2.O; System Code: 722028. The Allura Xper FD series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including…
    Category
    Distribution
    2 states