Recall Z-2633-2017 ยท IYE Accelerator, Linear, Medical
Elekta, Inc.
MOSAIQ(R) Oncology Information System, Versions 2.50.05 and higher Product Usage: 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. Users can configure MOSAIQ for Medical Oncology use, Radiation Oncology
| Date | Jun 21, 2017 |
| Status | Terminated |
| Reason | Retention of Outdated Information in an Order Set. In the Care Plan Library, double clicking to add or delete a Component/Procedure to an Order Set does not trigger the update of the associated Care Plans. |
| Root cause | Software design |
| Action | Elekta sent an Urgent Important Field Safety Notification letter dated June 2017. The notice informs users of the specific product and version numbers affected by the issue, and any work arounds that can be used to avoid the issue. Customers are instructed that a copy of the Important Field Safety Notice is to be kept with the most current labelling and all personnel working with the product should be made aware of the content of the letter. The customers are instructed to complete and return the Important Field Safety Notice Acknowledgement form to their local Elekta representative as soo |
| Quantity | 355 units |
| Distribution | Worldwide Distribution - US Nationwide and the countries of ANTIGUA AND BARBUDA, AUSTRALIA, AUSTRIA, BAHRAIN, CANADA, CHEZ REPUBLIC, GERMANY, HUNGARY, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWEDEN, AND UK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123230 | MOSAIQ ONCOLOGY INFORMATION SYSTEM Impac Medical Systems, Inc., Dec 12, 2012 |