Recall Z-1030-2011 ยท JAI Couch, Radiation Therapy, Powered
Elekta, Inc.
Precise Treatment Table The Precise Treatment Table is intended as a universal patient treatment support and positioning table for radiation therapy and simulation use. It is for use with existing Elekta Linear Accelerators and Simulators and adaptable to third party radiotherapy products.
| Date | Feb 3, 2011 (initiated Mar 10, 2008) |
| Status | Terminated |
| Reason | Possible error in the table longitudinal position. |
| Root cause | Other |
| Action | Elekta sent an updated IMPORTANT NOTICE letter dated December 24, 2008, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Elekta recommended that all users, and Eleckta field service engineers do regular QA checks to compare the movement of the treatment table in a given axis with the digital readout. Elekta Service representatives would attach the screws with Loctite and calibrate the axis on these sites. For questions regarding this recall call 770-670-2548. |
| Quantity | 597 units |
| Distribution | Nationwide Distribution and Puerto Rico |
| 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 |