—#133833

Product

Elekta Precise Treatment Table

FDA product code: JAI — Couch, Radiation Therapy, Powered
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K983678
Affected lot / code info: 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+)

Why it was recalled

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.

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

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.

Recalling firm

Firm: Elekta, Inc.
Address: 400 Perimeter Center Ter Ne, Ste 50, Atlanta, Georgia 30346-1227

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2015-01-29
Posted by FDA: 2015-03-19
Terminated: 2021-11-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #133833. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.