Recall Z-0075-2008 ยท KXJ Table, Radiologic
GE Healthcare
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
| Date | Nov 8, 2007 (initiated Aug 1, 2007) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 96 |
| Distribution | 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, SPA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.