Elekta, Inc.
Elekta Synergy The Elekta Synergy System is intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
| Date | Aug 29, 2011 (initiated May 6, 2011) |
| Status | Terminated |
| Reason | A small number of the Modular Reverse Diodes (D1A), a component in the equipment room of the Elekta Linear Accelerator, have ruptured. |
| Root cause | Other |
| Action | ELEKTA sent an IMPORTANT NOTICE (FCO 20000103022), dated May 6, 2011. The notice identified the product, the problem, and the aciton to be taken by the customer. Elekta recommended that service personnel always wear protective safety glasses, when they do work on the modulator assembly with the covers removed. Elekta also recommended that users make sure that the modulator cover is installed when the digital accelerator is in operation. Elekta will release a Field Change Order when a corrective action is identified. |
| Quantity | 368 |
| Distribution | Nationwide and Puerto Rico |
| FDA record | Open on fda.gov |