Device Recall Philips 의 리콜

Recall

72571

Class 2

Z-0765-2016

2015-11-03

2016-02-05

Terminated

United States

2016-08-19

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141539

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 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.