iGUIDE P10603-110Recalls & reported problems
3C-Medical Intelligence GmbH · iGUIDE Software 2.2.1 is the software which controls the movement of 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04056719001742), received between Jun 12, 2017 and Jun 12, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Computer Software Problem” (1 report).
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 ↗
Most reported problems
Device problems
- Computer Software Problem1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 12, 2017Computer Software Problem; Computer Software Problem
THE MANUFACTURER DISCOVERED DURING AN IN-HOUSE INVESTIGATION THAT IF THE PEC DATA DIALOG AFTER A VERIFICATION SCAN IS CANCELLED, A RE-SEND OF PEC DATA WILL LEAD TO INCORRECT POSITIONING BECAUSE THE 2ND PEC VALUES SUPERSEDE THE 1ST PEC VALUES INSTEAD OF BEING ADDED.
Patient problems: No Patient Involvement
MAUDE report 6633208 ↗
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 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 · each report above links to its original FDA record
- 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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