The Recall Desk

FDA (Devices) recall action 69339

Philips Medical Systems, Inc. recalled 2 products on 2016-04-06

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
2016-04-06
Critical
0
Units
4,348

Why these products were recalled

Loss of key image functionality due to a bent pedal of the Footswitch.

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.

1–2 of 2

  • ModerateFDA (Devices)··2016-04-06

    Philips Medical Systems Recalls Foot Switches for Bent Pedal Defect

    Philips Medical Systems is recalling 4,180 foot switches used with Allura Xper systems because a bent pedal can cause loss of key image functionality.

    Product
    Foot Switches used with the following systems: Philips Allura Xper Systems; 722001 AlluraXperFDlO C, 722002 Allura Xper FD1O F, 722003 Allura Xper FD1O, 722005 Allura Xper FD1O/10, 722006 Allura Xper FD2O, 722008 Allura Xper FD2O Biplane, 722010 Allura Xper FD1O, 722011 Allura…
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    0 states
  • ModerateFDA (Devices)··2016-04-06

    Philips MultiDiagnost Eleva Foot Switches Recalled for Bent Pedal Defect

    Philips Medical Systems is recalling 168 foot switches used with the MultiDiagnost Eleva system because a bent pedal can cause loss of key image functionality.

    Product
    Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038 This Philips MultiDiagnost Eleva is intended to be used as a multifunctional/universal system. General RIF, Fluoroscopy, Radiography and Angiography can be performed along with…
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    Distribution
    0 states