U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Radiolgic Table - Product Code KXJ
원인
Design problems including: 1) hot brake (longitudinal overheating) potential risk of burns 2) brake locks and sudden releases 3) emergency stop circuit button; open instead of closed 4) longitudinal brakes release does not engage properly 5) tilting movement causing tabletop to slide; may cause risk of pinched fingers to patient and/or operator 6) lodging pins on floor uncovered; may cause potenti.
조치
Recalling firm initiated correction by visit on August 2007. Corrections include replacement of one or more of the following: charger board, pin lodging, rear bumper. Also, replace the interface board and remove resistor mounted on chassis, remove brake pedal and assembly of cosmetic brake or apply caution labels.
Class II Recall - Worldwide Distribution --- USA including States of -- AL, CA, FL, GA, IA, IL, IN, LA, ND, NY, OH, PA, TX, and WI, and Countries of -- BELGIUM, CZECH REPUBLIC, FINLAND, FRANCE, GERMANY, GUAYANA, HONG KONG, HUNGARY, IRELAND, ISRAEL, ITALY, KUWAIT, LATVIA, LEBANON, SAUDI ARABIA, SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM.
제품 설명
Sunisa Flexi-DT Table, Model Numbers: 51335678, 2269647, 2242088-2, 5141609-2, 5115763, and 5128145, || Manufactured by Suinsa C Primavera, 39 Pol. Ind. Las Monjas, Tarrejon de Ardaz Madrid 28850 Spain