Elekta Synergy The Elekta Synergy System is intended to be used for radiation therapy treatment of malignant neoplastic
FDA device recall Z-3079-2011 · posted 2011-08-29 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- A small number of the Modular Reverse Diodes (D1A), a component in the equipment room of the Elekta Linear Accelerator, have ruptured.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Quantity affected
- 368
- Distribution
- Nationwide and Puerto Rico
- Date initiated
- 2011-05-06
- Date posted
- 2011-08-29
- Date terminated
- 2012-10-02
- Location
- Norcross, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5 (K051932) | Elekta, Inc. | 2005-08-12 |
| ELEKTA SYNERGY SYSTEM (K032996) | Elekta Oncology Systems, Ltd. | 2003-10-23 |
| PHILIPS SLI SERIES LINEAR ACCELERATOR (K963624) | Philips Medical Systems, Inc. | 1996-12-06 |