Elekta Synergy Intended to be used for radiation therapy treatment of malignant neoplastic diseases.
FDA device recall Z-1441-2010 · posted 2010-04-27 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- Installation of a touchguard to prevent injury to patients or staff by stopping machine movements in the case of accidental collision.
- Action taken
- 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 Source touchguard for systems with the original source covers" dated 10/17/08 was sent to all affected customers.
- Root cause
- Finished device change control
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 184 units
- Distribution
- Nationwide Distribution -- Including Puerto Rico.
- Date initiated
- 2008-03-18
- Date posted
- 2010-04-27
- Date terminated
- 2010-12-14
- 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 SYSTEM (K032996) | Elekta Oncology Systems, Ltd. | 2003-10-23 |