Recall Z-0557-2016 ยท IYE Accelerator, Linear, Medical
Elekta, Inc.
MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.
| Date | Dec 9, 2015 |
| Status | Terminated |
| Reason | Incorrect drug dosage due to "Age Limit" and patient weight data item issue. |
| Root cause | Software design |
| Action | The firm, Elekta, sent an "URGENT IMPORTANT FIELD SAFETY NOTICE 371-01-MSQ-005" to all customers on 12/9/2015. The notice informs users of the specific product and version numbers affected by both issues, also includes a workaround for both issues. A copy of the Important Field Safety Notice is to be kept with the most current labeling and all personnel working with the product should be made aware of the content of the letter. The customers are instructed to return the acknowledgement form to their local Elekta as soon as possible-Fax: 408-830-8003. If you have any queries about this Noti |
| Quantity | 399 |
| Distribution | Worldwide Distribution: US (nationwide) including states of: AK, AZ, AR, CA, CO, CT, DE DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, ,MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, and WY; and countries of: Antiqua & Barbuda, Australia, Austri |
| 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 |