Recall Z-2052-2016 ยท IYE Accelerator, Linear, Medical
Elekta, Inc.
MOSAIQ Oncology Information System
| Date | Jun 17, 2016 |
| Status | Terminated |
| Reason | It is possible that that the selected Plan-of-the Day could be accidently changed by scrolling the mouse wheel up and down and inadvertently selecting another plan. |
| Root cause | Software design |
| Action | Elekta sent an Important Field Safety Notice to all customers on June 17, 2016. The notice informs users of the specific product and version numbers affected by the issue, and any work around that can be used to avoid the issue. A software patch will be issued for Mosaiq version 2.62 in order to the correct the defect. For further questions please call (404) 993-5886. |
| Quantity | 69 |
| Distribution | US Distribution including Puerto Rico and to the states of : AK, AZ, CA, FL, GA, IL, IN, LA, MD, MI, MO, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and to the countries of : Canada, Denmark, Finland, Germany, Israel, Japan, Netherlands, Norway, Sweden, United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141572 | MOSAIQ ONCOLOGY INFORMATION SYSTEM Impac Medical Systems, Inc., Sep 5, 2014 |