Recall Z-1238-2015 ยท JAI Couch, Radiation Therapy, Powered
Elekta, Inc.
Elekta Precise Treatment Table
| Date | Mar 19, 2015 (initiated Jan 29, 2015) |
| Status | Terminated |
| Reason | 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 | 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 |
| Quantity | 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, Eg |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983678 | ELEKTA ONCOLOGY SYSTEMS PRECISE TREATMENT TABLE Elekta Instruments, Inc., Jan 15, 1999 |