Schwabmunchen, N/A, Germany
Medical Intelligence Medizintechnik Gmbh recalls
1 recall recorded since 2018, most recently on 18 July 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 18 July 2019
- Terminated
- 11 August 2023
- 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.
- Distribution
- Worldwide Distribution - US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2082-2019
- 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 ra
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.