Elekta Synergy XVI 4.5 and R4.6 To be used as part of radiation therapy treatment process.
FDA device recall Z-1066-2012 · posted 2012-02-21 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- If a user, using an on-line correction protocol, clicks the accept correction button, an approval dialog box appears. If cancel is selected, the table correction values return to their initial values, but the image panes continue to display the changed position.
- Action taken
- ELEKTA sent an Important Field Safety Notice (20001507042) dated January 2012 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. For questions regarding this recall call 770-670-2548
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 96 units
- Distribution
- Nationwide Distribution including AR, AZ, CA, CT, FL, GA, ID, IL, LA MD, MA, MI, MN, MO, NJ, NY, NC, ND, OH, OK, OR, PA, RI, TN, VA, WA, WI, and Puerto Rico
- Date initiated
- 2012-01-26
- Date posted
- 2012-02-21
- Date terminated
- 2012-04-17
- 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 |
|---|---|---|
| XVI R4.5 (K100115) | Elekta , Ltd. | 2010-03-10 |