CardioGraphe SpotlightRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07290016484007), received between Mar 18, 2025 and Mar 18, 2025 — classified as 1 malfunction.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2025No Apparent Adverse Event; No Apparent Adverse Event

  MANUFACTURER NARRATIVE: ARINETA IS CONDUCTING A THOROUGH INVESTIGATION OF THE REPORTED EVENT. AS THIS EVENT IS UNDER INVESTIGATION, A ROOT CAUSE HAS NOT YET BEEN DETERMINED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. EVENT DESCRIPTION: IT WAS REPORTED BY (B)(6) HOSPITAL, THAT SPARKS AND SMOKE WERE OBSERVED COMING FROM THE BOTTOM OF THE GANTRY COVERS DURING A PATIENT SCAN. THE SCAN PROTOCOL WAS COMPLETED WITH NO CONTRAST, AND NO HARM WAS REPORTED TO THE PATIENT. UPON FURTHER INVESTIGATION, THE FIELD ENGINEERS OPENED THE POWER DISTRIBUTION UNIT (PDU) COVERS AND DISCOVERED SMOKE COMING FROM THE AC/DC BOX. FURTHER INSPECTION OF THE GANTRY SHOWED VISUAL DAMAGE TO THE SLIP RING INSIDE THE GANTRY. THERE HAVE BEEN NO REPORTS OF ANY IMPACT TO THE HEALTH OR SAFETY OF THE PATIENT OR USER INVOLVED. ARINETA HAS REQUESTED ADDITIONAL INFORMATION TO FURTHER INVESTIGATE THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21633179 ↗