The Recall Desk

FDA (Devices) recall action 72571

Philips Electronics North America Corporation recalled 2 products on 2016-02-17

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
2016-02-17
Critical
0
Units
17

Why these products were recalled

Normally, movement of the C-arc is initially stopped by the motor (holding torque) then by the electromagnetic brake, leading to a full stop of the C-arc. Because of improper adjustment and tolerances, when the C-arc is initially stopped in an unbalanced position, the air gap of the brake can become too large, resulting in continued C-arc movement (C-arc is looking for balanced position).

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

  • HighFDA (Devices)··2016-02-17

    Philips Allura Xper FD20 Ceiling Version Recalled for C-Arc Movement

    Philips is recalling 15 Allura Xper FD20 Ceiling version units because improper adjustment may cause the C-arc to continue moving after stopping.

    Product
    Philips Allura Xper FD20 Ceiling version only; 722028; imaging applications.
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2016-02-17

    Philips Allura Xper FD OR Table Recalled for C-Arc Movement Issue

    Philips is recalling two Allura Xper FD OR Tables because the C-arc may continue moving after stopping due to improper adjustment.

    Product
    Allura Xper FD OR Table, Ceiling version only; 722035; imaging applications.
    Category
    Distribution
    2 states