The Recall Desk
SevereFDA (Devices)·Z-0765-2016·Announced 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.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, an FDA Class II recall involving a structural defect that poses a risk of injury (uncontrolled movement of a heavy medical device component) is rated as Severe.

Plain-English summary

Philips Electronics North America Corporation is recalling two units of the Allura Xper FD OR Table, Ceiling version only (model 722035). The recall is due to a defect where the C-arc may continue moving after it is initially stopped.

The issue occurs because of improper adjustment and tolerances. When the C-arc is stopped in an unbalanced position, the air gap of the electromagnetic brake can become too large, preventing a full stop and causing the C-arc to keep moving as it looks for a balanced position.

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 should contact the manufacturer for correction and removal of the affected units.

The recalled product

Product
Allura Xper FD OR Table, Ceiling version only; 722035; imaging applications.
Affected units
2

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 →

Same manufacturer · Philips Electronics North America Corporation

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