Recall Z-2082-2019 ยท IYE Accelerator, Linear, Medical
Medical Intelligence Medizintechnik Gmbh
IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.
| Date | Jul 18, 2019 |
| Status | Terminated |
| Reason | Sometimes, although the HexaPOD has reached the target position, the Constant Correlation Check (CCC) can be too sensitive and iGUIDE may incorrectly demand a verification scan. |
| Root cause | Software design |
| Action | The firm sent an Urgent Important Field Safety Notification letter dated July 2019 via email. The identified the affected product, problem and actions to be taken. Customers were instructed to post this notice in a place accessible to all users, e.g. Instructions for Use, until this action is closed and advise the appropriate personnel, working with this product, on the content of this letter. |
| Quantity | 496 units |
| Distribution | Worldwide Distribution - US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072079 | IGUIDE SYSTEM Medical Intelligence Medizintechnik-GmbH-An Elekta, Aug 14, 2007 |