The Recall Desk

FDA (Devices) recall action 82459

Philips Medical Systems Nederlands recalled 2 products on 2019-04-24

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
2019-04-24
Critical
0
Units
14,418

Why these products were recalled

Additional units have been identified for previous recall Z-1280-2016 (RES 69339): If a Footswitch is frequently used on a non-flat surface or in the pedestal, the footswitch pedals may get bent. This might cause an intermittent or continuous inability of making live fluoroscopy images or exposures.

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

  • ModerateFDA (Devices)··2019-04-24

    Philips Medical Systems Recalls Foot Switches for Allura Xper Systems

    Philips Medical Systems is recalling 7,209 foot switches used with Allura Xper systems because pedals may bend, causing an inability to make live fluoroscopy images or exposures.

    Product
    Foot Switches used with the following systems: 722001 Allura Xper FD 10 C 722002 Allura Xper FD10 F 722003 Allura Xper FD10 722005 Allura Xper FD10/10 722006 Allura Xper FD20 722008 Allura Xper FD20 Biplane 722010 Allura Xper FD10 722011 Allura Xper FD10/10 722012…
    Category
    Distribution
    7 states
  • ModerateFDA (Devices)··2019-04-24

    Philips Medical Systems Recalls Foot Switches for Imaging Systems

    Philips Medical Systems is recalling 7,209 foot switches used with specific imaging systems because bent pedals may prevent live fluoroscopy images or exposures.

    Product
    Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038 Product The Allura Xper FD Series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic…
    Category
    Distribution
    7 states