FDA Device recall Z-2082-2019
IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator
- FDA Device
- Class II
- terminated
- Published 2019-07-31
On 2019-07-31 the FDA classified a Class II recall of IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator by Medical Intelligence Medizintechnik, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2082-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-07-18 |
| Published | 2019-07-31 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Medical Intelligence Medizintechnik |
| Distribution | US |
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
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.
Identifiers
| code_info | UDI (GTIN) iGuide 2.2.0 = 04056719001704 iGuide 2.2.1 = 04056719001742 iGuide 2.2.2 = 04056719002039 Installed o…UDI (GTIN) iGuide 2.2.0 = 04056719001704 iGuide 2.2.1 = 04056719001742 iGuide 2.2.2 = 04056719002039 Installed on the following units: Master Devices with serial numbers: VERSA HD/30002624-003/154166 VERSA HD/30000782-003/153788 VERSA HD/30000782-003/153788 VERSA HD/30000782-003/153788 ELEKTA INFINITY/19175-003/154363 VERSA HD/30001056-002/109016 VERSA HD/30001009-001/153427 ELEKTA INFINITY/11766-003/152570 VERSA HD/11766-004/153649 ELEKTA SYNERGY/11766-002/151717 VERSA HD/17114-001/153383 VERSA HD/19677-005/109018 VERSA HD/30003910-LIN001/109005 VERSA HD/30003903-LIN001/109006 VERSA HD/30003903-LIN002/109035 VERSA HD/30001230-003/153428 VERSA HD/15081-LIN003/109003 ELEKTA SYNERGY/15081-002/152131 VERSA HD/12486-003/109036 VERSA HD/15240-003/109033 ELEKTA SYNERGY/15240-001/152128 ELEKTA SYNERGY/15240-002/152419 ELEKTA SYNERGY/20967-001/153012 VERSA HD/30003249-001/154299 VERSA HD/14756-002/153003 ELEKTA SYNERGY/14756-001/151916 ELEKTA SYNERGY/12579-00 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2082-2019%22
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