| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00996-1 |
| Product Name/Description |
MOSAIQ (Radiation Oncology Information System). All releases pre version 2.41
ARTG Number: 180498 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
18/10/2012 |
| Responsible Entity |
|
| Reason/Issue |
A patient was mistreated after a user made and saved an inadvertent change to the definition of a treatment field in MOSAIQ. The mistreatment occurred at a site that had disabled the Field Edit Display feature. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Elekta is providing instructions to enable the Field Edit Delta Display Option and recommends upgrading to software version 2.41 or higher |
| Contact Information |
02 8907 1800 - Elekta Regulatory Affairs |