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Class 2 Device Recall Precise Treatment Table |
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Date Initiated by Firm |
January 29, 2015 |
Date Posted |
March 19, 2015 |
Recall Status1 |
Terminated 3 on November 05, 2021 |
Recall Number |
Z-1238-2015 |
Recall Event ID |
70458 |
510(K)Number |
K983678
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Product Classification |
Couch, radiation therapy, powered - Product Code JAI
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Product |
Elekta Precise Treatment Table |
Code Information |
Precise Treatment Table Serial Numbers: (124001-125803, 125807-880, 125883-899, 125902-917, 125920-949, 125952-963, 125966-1256453, 126158-170, 126174-208, 126212-230, 126232-261, 126269-281, 126293-309,123318-330, 126338-126373, 126375-397, 126400-133999, 213000+) |
Recalling Firm/ Manufacturer |
Elekta, Inc. 400 Perimeter Center Ter Ne Ste 50 Atlanta GA 30346-1227
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For Additional Information Contact |
770-300-9725
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Manufacturer Reason for Recall |
It is possible to position the Treatment Table with errors greater than 5mm and no inhibits are displayed, if the positional sensors are not correctly installed during corrective maintenance. Clinical mistreatment may occur if a position error is not detected.
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FDA Determined Cause 2 |
Radiation Control for Health and Safety Act |
Action |
Planned Action by Elekta:
1. Notifications have been sent out. The notification informs users of the possibility treatment table position errors might occur if there is a maintenance error when replacing a potentiometer. The notification recommends establishing a procedure to verify the accuracy of the treatment table position as shown by the treatment room monitor which is performed as part of the daily machine checks. An example procedure is provided.
2. Elekta will establish a procedure service engineers will follow after maintenance involving the relevant potentiometers to ensure proper installation.
The procedure will be taught using a video which includes a step by step guide to the correct methodology for installation of the potentiometer assembly, a description of the impact for not installing correctly, and a guide to the new verification of correct installation procedure. The video will be distributed through Elektas learning management system (LMS). The LMS maintains a record of service engineers who successfully complete the training.
3. Elekta will implement an engineering change to the potentiometer assembly which applies to the manufacture of all new Precise Treatment Tables. This change will eliminate the potential for incorrect installation and will prevent a loose grub screw from causing backlash. This change is expected to consist of a 'D' shaped bore that cannot spin on the shaft of the potentiometer.
All actions associated with this correction, including service engineer training, will be completed by June 2015. For further questions please call (770) 300-9725. |
Quantity in Commerce |
529 US 2951 Worldwide |
Distribution |
Worldwide Distribution - USA (nationwide) Distribution and to the countries of Albania, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Lebanon, Libya, Lithuania, Malaysia, Malta, Mexico, Morocco, Myanmar, Namibia, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland and Syria. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = JAI and Original Applicant = ELEKTA INSTRUMENTS, INC.
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