iGUIDERecalls & reported problems across all models

We found 3 models of iGUIDE by 3C-Medical Intelligence GmbH in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, 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 at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

iGUIDE recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. 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 · names 3 of these models · Recall details · FDA record ↗

2. Jun 19, 2019Terminated

   Potential for iGUIDE to incorrectly monitor the 3D position.

   Z-2230-2019 · Root cause: Software Design Change · names 3 of these models · Recall details · FDA record ↗

Most reported iGUIDE problems

iGUIDE models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• iGUIDE P10603-110

  Accelerator, Linear, Medical
  2 recalls1 report
• iGUIDE P10603-109

  Accelerator, Linear, Medical
  2 recalls0 reports
• iGUIDE P10603-111

  Accelerator, Linear, Medical
  2 recalls0 reports

Recent iGUIDE adverse event reports

The 1 most recent reports across all models, 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 ↗