Recall Z-1555-2011 ยท IYE Accelerator, Linear, Medical
Elekta, Inc.
Desktop Pro 4.2, 5.0, 5.1, 6.0, 6.2 A user interface of rthe SL/SLi Series Linear Accelerators that are used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.
| Date | Mar 4, 2011 (initiated Aug 23, 2007) |
| Status | Terminated |
| Reason | Under certain conditions it has been found that movement of the collimators can be induced during multi segment beams such as IMRT and Omniwedge which will not be detected by the Desktop Pro if high values are sent within the iCom tolerance table. |
| Root cause | Other |
| Action | The firm, Elekta, sent an "Important Notice A302" dated August 23, 2007 titled "Update to iCom Tables for Desktop Pro when used with Third Party R&V Systems",to all affected customers. On September 28, 2007, Elekta issued a second Important Notice A304 which reiterated the same information as was in Important Notice A302. The notices described the product, problem and actions to be taken. This notice provides a workaround on how to avoid the issue. In order to avoid this issues documented, Elekta recommended that the customers set the tolerance for collimators in the iCom tolerance table to b |
| Quantity | 229 units |
| Distribution | Worldwide distribution: USA including Puerto Rico and countries including: Canada and Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982713 | RT DESKTOP Elekta Oncology Systems, Ltd., Nov 2, 1998 |