Elekta Precise Treatment Table

FDA device recall Z-1238-2015 · posted 2015-03-19 · Terminated

Recall details

Recalling firm

Elekta, Inc.

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.

Action taken

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.

Root cause

Radiation Control for Health and Safety Act

Status

Terminated

Product code

JAI

Quantity affected

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, B

Date initiated

2015-01-29

Date posted

2015-03-19

Date terminated

2021-11-05

Location

Atlanta, GA

Related 510(k) clearances