Recall Z-1441-2010 ยท IYE Accelerator, Linear, Medical
Elekta, Inc.
Elekta Synergy Intended to be used for radiation therapy treatment of malignant neoplastic diseases.
| Date | Apr 27, 2010 (initiated Mar 18, 2008) |
| Status | Terminated |
| Reason | Installation of a touchguard to prevent injury to patients or staff by stopping machine movements in the case of accidental collision. |
| Root cause | Finished device change control |
| Action | An Important Notice A319 "Instructions for Use for Elekta Synergy kV Source Touchguard" dated 3/18/08 is in distribution to all affected customers. This letter identified the product and asked customers to file the Notice in the User Notice section of the appropriate User Manual. It also asked them to follow the instructions and the reason for the Notice. Questions should be directed to a local Elekta representative. Field Change Order (FCO) 514 259 "kV Source touchguard for systems with touchguard ready source covers" dated 10/17/08 was sent to all affected customers. FCO 514 260 "kV Sou |
| Quantity | 184 units |
| Distribution | Nationwide Distribution -- Including Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032996 | ELEKTA SYNERGY SYSTEM Elekta Oncology Systems, Ltd., Oct 23, 2003 |