Sunisa Flexi-DT Table, Model Numbers: 51335678, 2269647, 2242088-2, 5141609-2, 5115763, and 5128145, Manufactured by Sui

FDA device recall Z-0075-2008 · posted 2007-11-08 · Terminated

Recall details

Recalling firm

GE Healthcare

Reason for recall

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

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

KXJ

Quantity affected

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, GERMAN

Date initiated

2007-08-01

Date posted

2007-11-08

Date terminated

2008-03-02

Location

Waukesha, WI