NEUWAVE NWA1US1NRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00853719006951), received between Apr 8, 2022 and Apr 8, 2022 — classified as 1 injury.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• InjuryApr 8, 2022Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, CT TECH ALERTED ME THAT THEY HAD A CASE IN LATE 2021, EXACT DATE UNKNOWN RIGHT NOW BUT SHE IS INVESTIGATING, WHERE THE CERTUS 140 CAUSED THEIR SIEMENS SCANNER TO SHUTDOWN COMPLETELY. CERTUS 140 WAS SET UP WITHIN A FEW FEET OF THE SCANNER. THE PDM WAS CLAMPED TO BED PLATE ON THE CT SCANNER. THIS INCIDENT RESULTED IN PATIENT INJURY. AS THIS HAS JUST BEEN REPORTED TO ME, THE PROBE LOT IS UNKNOWN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS PATIENT CONSEQUENCES. PATIENT HAD A 3RD DEGREE BURN AND WAS TREATED FOR IT.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 14054544 ↗