Recall Z-1064-2014 ยท IYE Accelerator, Linear, Medical
Elekta, Inc.
SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.
| Date | Mar 14, 2014 (initiated May 28, 2013) |
| Status | Terminated |
| Reason | Customers are resetting the default values outside recommended factory settings. |
| Root cause | Device Design |
| Action | The firm, Elekta, sent an "Important Field Safety Notice (IFSN 200 01 103 073 - Electron Applicator Auto-Tracking Defaults)" released on May 28, 2013 and is in the process of being distributed to all customers. The Notice requests users to please adhere to the instructions and advice given in manuals and system dialogues, which explicitly state that a change to auto-tracking values could compromise compliance with safety standards and can cause increased unwanted radiation dose to the patient. All machines should be checked against the default settings attached. If the actual settings are g |
| Quantity | 449 |
| Distribution | Worldwide Distribution: US (Nationwide) including states of: AK, CA, CT, FL, IL, IN, IA, LA, MD, MA, MI, MN, NJ, NY, OH, OK, OR, PA, TN, TX, VA, WA, WV, and Puerto Rico; and countries of: Argentina, Australia, Austria, Belarus, Belgium, Bosnia & Herzegovinia, Brazil, Canada, China, Czech Republic, D |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K963624 | PHILIPS SLI SERIES LINEAR ACCELERATOR Philips Medical Systems, Inc., Dec 6, 1996 |