Drug recall
IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of…
FDA recall event 83358 · Class II · Medical Intelligence Medizintechnik Gmbh
Key facts
| Event ID | 83358 |
|---|---|
| Recall numbers | Z-2082-2019 |
| Recalling firm | Medical Intelligence Medizintechnik Gmbh |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 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. |
| Initiation date | Jul 18, 2019 |
| Report date | Jul 31, 2019 |
| Termination date | Aug 11, 2023 |
| City | Schwabmunchen |
| Country | Germany |
| FEI number | 3003251135 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: