Precise Treatment Table Intended as a universal patient treatment support and positioning table for radiation therapy and simulation use.
This recall has been terminated (originally issued April 23, 2010).
- Company
- Elekta, Inc.
- Recall Initiated
- January 11, 2007
- Posted
- April 23, 2010
- Terminated
- December 28, 2010
- Recall Number
- Z-1432-2010
- Quantity
- 185 units
- Firm Location
- Norcross, GA
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
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.
Root Cause
Other
Action Taken
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.