Recall Z-1072-2013 ยท JAI Couch, Radiation Therapy, Powered
Elekta, Inc.
Precise Treatment Table. To be used as part of radiation therapy treatment process.
| Date | Apr 9, 2013 (initiated Mar 14, 2013) |
| Status | Terminated |
| Reason | The Column rotation can accidentally be moved to a different position which in the locked position. |
| Root cause | Device Design |
| Action | Elekta sent an "IMPORTANT FIELD SAFETY NOTICE" dated March 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact your local Elekta office for questions about this notice. |
| Quantity | 443 |
| 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 |