iGUIDE P10603-111Recalls & reported problems
3C-Medical Intelligence GmbH · iGUIDE Software 2.2.2 is the software which controls the movement of the the HexaPOD™ evo Module and monitors the correct position of the module · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
2 FDA recall records name this device's identifier.
1 other recall cover devices cleared under the same FDA submission (K143485); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Jul 18, 2019Terminated
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.
Z-2082-2019 · Root cause: Software design · FDA record ↗
- Jun 19, 2019Terminated
Potential for iGUIDE to incorrectly monitor the 3D position.
Z-2230-2019 · Root cause: Software Design Change · FDA record ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K143485. One submission often covers many models, so check the product and lot details in each record.
- Z-3017-2017 · Jun 19, 2017 · TerminatediGUIDE Software 2.2 Product Usage: Control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.
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- Elekta Medical Linear Accelerator 1552093Elekta Solutions AB · Accelerator, linear, medical5 recalls6 reports
- Elekta Medical Linear Accelerator 1552092Elekta Solutions AB · Accelerator, linear, medical5 recalls0 reports
- MOSAIQ 3.2Elekta Solutions AB · Accelerator, Linear, Medical4 recalls25 reports
- Elekta Medical Linear Accelerator 1550358Elekta Solutions AB · Accelerator, linear, medical4 recalls2 reports
- Elekta Medical Linear Accelerator 1552091Elekta Solutions AB · Accelerator, linear, medical4 recalls1 report
- Elekta Medical Linear Accelerator 1550359Elekta Solutions AB · Accelerator, linear, medical4 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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