Elekta Synergy XVI R.4.5 and R4.6 ProducT Usage: To be used as part of radiation therapy treatment process.
FDA device recall Z-0320-2012 · posted 2011-12-01 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- The software did not operate as expected.
- Action taken
- Elekta sent an IMPORTANT NOTICE letter dated October 14, 2011 to all affected consignees. The letter identified the affected product, the problem, and the actions to be taken. This notice contained precautionary measures that are required for the operation of the equipment. The notice advise all customers to follow any instructions or recommendations covered in the Notice. The notice instructs Users to file this document in the Important Notice section of the appropriate User Manual. For questions contact your local Elekta representative.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 77
- Distribution
- Nationwide Distribution (USA) - including the states of: AZ, CA, CT, 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
- 2011-10-14
- Date posted
- 2011-12-01
- Date terminated
- 2014-11-03
- 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 |