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.
Recall
- Recall Number
- Z-2082-2019
- Event Number
- 83358
- Firm
- Medical Intelligence Medizintechnik Gmbh Robert-bosch-str. 8 Schwabmunchen Germany
- FEI Number
- 3003251135
- Product Code
- IYE
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- July 18, 2019
- Terminated
- August 11, 2023
Description
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.
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.
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.
Worldwide Distribution - US Nationwide
496 units