Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Philips Allura Xper FD20 Ceiling version only; 722028; imaging applications.

FDA Recall Z-0764-2016 · Posted 2016-02-05

Recall StatusTerminated
Product CodeOWB
Date Initiated2015-11-03
Date Terminated2016-08-19
Product Quantity15 subject to correction and removal

Reason for Recall

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).

Firm 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.

Root Cause

Device Design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑