CT-SPOT 118Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00815137020070), received between Jul 19, 2019 and Sep 2, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (1 report).

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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 2, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A CT SIMULATION SKIN MARKER WAS USED UNDER A BOLUS FOR A CT-SCAN RESULTING IN AN AIR GAP ARTIFACT. AS A RESULT, THE CT-SCAN WAS REPEATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22939672 ↗
• InjurySep 9, 2019Signal Artifact/Noise

  A CT-SPOT MAY HAVE CAUSED ARTIFACT ON A PATIENT'S CT SCAN. AS A RESULT, THE CT SCAN WAS REPEATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8976500 ↗
• InjuryJul 19, 2019Display or Visual Feedback Problem

  A CT-SPOT MAY HAVE CAUSED ARTIFACT ON A PATIENT'S CT SCAN. AS A RESULT, THE CT SCAN WAS REPEATED.

  Patient problems: No Code Available

  MAUDE report 8808172 ↗