IGuide System — Class II medical device recall Z-2082-2019
Terminated recall by Medical Intelligence Medizintechnik Gmbh, reported 2019-07-31, distributed nationwide. Sometimes, although the HexaPOD has reached the target position, the Constant Correlation Check (CCC) can be t
| Recall number | Z-2082-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medical Intelligence Medizintechnik Gmbh, Schwabmunchen, N/A, Germany |
| Recall initiated | 2019-07-18 |
| Classified | 2019-07-25 |
| Reported by FDA | 2019-07-31 |
| Terminated | 2023-08-11 |
| Distributed | Nationwide (US) |
| Quantity | 496 units |
| UPC / GTIN / UDI-DI | 04056719001704, 04056719001742, 04056719002039 |
Product
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2082-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.