Philips Electronics North America Corporation: Allura Xper FD OR Table, Ceiling version only; 722035; imaging applications.

Recall number

Z-0765-2016

Recalling firm

Philips Electronics North America Corporation

Product

Allura Xper FD OR Table, Ceiling version only; 722035; imaging applications.

Status

Terminated

Initiated

2015-11-03

Posted

2016-02-05

Terminated

2016-08-19

Reason

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).

Root cause

Device Design

Action

The letters for the customers in the United States were sent on 11/3/2015, via certified return receipt and were addressed to the Risk Manager. Philips will perform a test on the 15 affected Allura Xper R8.2 FD 20C systems to see if the motion controller amplifier of the brake motor works correctly. If the test will not pass, the motor will be replaced. The Recall Package is sent to all Key Markets worldwide. The Key Market of an affected country will contact the facility where these systems were installed.

Quantity

2 subject to correction and removal

Distribution

Worldwide Distribution. US states of TN and IN and the countries of Australia, Belgium, Egypt, France, Germany, Japan, Republic of Korea, Netherlands, and Saudi Arabia.

Lot, serial or model codes

Ceiling version only.

510(k) numbers

["K102005"]

PMA numbers

not on file

Product code

OWB

Firm FEI

1218950

Firm city

Andover

Firm state

MA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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