Class 2 Device Recall Precise Treatment Table

• Date Initiated by Firm: January 11, 2007
• Date Posted: April 23, 2010
• Recall Status: Terminated on December 28, 2010
• Recall Number: Z-1432-2010
• Recall Event ID: 55103
• 510(K)Number: K983678
• Product Classification: Powered Radiation Therapy Couch - Product Code JAI
• Product: Precise Treatment Table; ; Intended as a universal patient treatment support and positioning table for radiation therapy and simulation use.
• Code Information: 103101, 105136, 105183, 105223, 105271, 105281, 105292, 105330, 105343, 105370, 105446, 105473, 105511, 105518, 105528, 105532, 105542, 105550, 105568, 151416, 151417, 151420, 151421, 151422, 151423, 151424, 151425, 151426, 151427, 151428, 151429, 151430, 151432, 151433, 151434, 151435, 151436, 151437, 151439, 151440, 151441, 151443, 151444, 151445, 151446, 151447, 151448, 151449, 151450, 151451, 151452, 151453, 151454, 151455, 151456, 151457, 151458, 151459, 151460, 151461, 151462, 151463, 151464, 151466, 151467, 151468, 151469, 151470, 151472, 151473, 151474, 151475, 151476, 151477, 151478, 151479, 151480, 151481, 151483, 151484, 151485, 151486, 151487, 151488, 151489, 151490, 151491, 151492, 151493, 151494, 151495, 151496, 151497, 151499, 151500, 151501, 151502, 151503, 151504, 151505, 151506, 151507, 151508, 151509, 151510, 151511, 151513, 151514, 151515, 151516, 151517, 151518, 151519, 151520, 151522, 151523, 151524, 151525, 151526, 151527, 151528, 151529, 151530, 151531, 151532, 151533, 151534, 151535, 151536, 151537, 151538, 151539, 151540, 151541, 151542, 151543, 151544, 151546, 151547, 151549, 151550, 151551, 151552, 151553, 151554, 151555, 151557, 151558, 151559, 151561, 151565, 151566, 151567, 151568, 151569, 151572, 151573, 151578, 151574, 151575, 151579, 151580, 151581, 151583, 151584, 151585, 151587, 151588, 151589, 151590, 151595, 151596, 151597, 151599, 151600, 151601, 151602, 151603, 151608, 151614, 151618, 151622, 151626, 151627, and 151628.
• Recalling Firm/ Manufacturer: Elekta, Inc.; 4775 Peachtree Industrial Blvd; Bldg 300, #300; Norcross GA 30092-3011
• For Additional Information Contact: Thomas Valentine; 770-670-2548
• Manufacturer Reason for Recall: In some instances, the bolts which are supplied with the table have sheared off, resulting in inability to operate the powered table.
• FDA Determined Cause: Other
• Action: Mandatory Field Change Order (FCO) 528 053 "Check for zinc plated Precise Table 'Z' mechanism fixation bolts", dated 1/11/2007 was distributed to all affected customers. The Change Order identified the product, stated the reason for the FCO, and the procedure to check and resolve the problem identified.
• Quantity in Commerce: 185 units
• Distribution: Worldwide Distribution -- USA, Puerto Rico, Argentina, Australia, Austria, Bangladesh, Belgium, Canada, China, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Iraq, Israel, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, Pakistan, Peru, Poland, Russia, Serbia, Spain, Sudan, Sweden, Taiwan, Thailand, Turkey & United Kingdom.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JAI and Original Applicant = ELEKTA INSTRUMENTS, INC.