The Recall Desk
HighFDA (Devices)·Z-0764-2016·Announced 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.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a mechanical defect in a medical device that could lead to unintended movement of the C-arc, posing a risk of injury, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Philips Electronics North America Corporation is recalling 15 units of the Philips Allura Xper FD20 Ceiling version (model 722028) used for imaging applications. The recall is due to a defect where improper adjustment and tolerances can cause the C-arc to continue moving after it has initially stopped.

The issue occurs when the C-arc is stopped in an unbalanced position, causing the air gap of the electromagnetic brake to become too large. This results in the C-arc continuing to move as it seeks a balanced position, rather than coming to a full stop as intended.

The affected units were distributed worldwide, including in the US states of Tennessee and Indiana, and in Australia, Belgium, Egypt, France, Germany, Japan, the Republic of Korea, the Netherlands, and Saudi Arabia. Users of these devices should contact Philips for correction and removal of the affected units.

The recalled product

Product
Philips Allura Xper FD20 Ceiling version only; 722028; imaging applications.
Manufacturer
Philips Electronics North America Corporation
Category
Medical Device — Imaging Equipment
Hazard
Affected units
15

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Ceiling version only.

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 2 recalled by Philips Electronics North America Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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