Events

Recall of Device Recall Precise Treatment Table

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Elekta, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    55103
  • Event Risk Class
    Class 2
  • Event Number
    Z-1432-2010
  • Event Initiated Date
    2007-01-11
  • Event Date Posted
    2010-04-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-12-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89897
  • Notes / Alerts
    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.
  • Extra notes in the data
    Powered Radiation Therapy Couch - Product Code JAI
  • Reason
    In some instances, the bolts which are supplied with the table have sheared off, resulting in inability to operate the powered table.
  • 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.

Device

Device Recall Precise Treatment Table
  • Model / Serial
    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.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    Precise Treatment Table || Intended as a universal patient treatment support and positioning table for radiation therapy and simulation use.
  • Manufacturer
    Elekta, Inc.

Manufacturer

Elekta, Inc.
  • Manufacturer Address
    Elekta, Inc., 4775 Peachtree Industrial Blvd, Bldg 300, #300, Norcross GA 30092-3011
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    USFDA