DEKA MOTUS AZ+ M130A1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08057017760566), received between Mar 8, 2024 and Mar 8, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Radiation Leak” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 8, 2024Radiation Leak; Radiation Leak

  ON FEBRUARY THE19TH, 2024, EL. EN. ELECTRONIC ENGINEERING SPA BECAME AWARE OF A MALFUNCTION, FROM CARTESSA'S (US IMPORTER) TECHNICIAN, THAT PERFORMED A SERVICE INTERVENTION ON THE MOTUS AZ+, INSTALLED AT WARNER INSTITUTE (ILLINOIS - USA) , IN WHICH THE SHUTTER BROKE AND CAUSED AN UNWANTED LASER EMISSION DURING THE LASER INITIAL CALIBRATION. THE ACTUAL DEVICE INVOLVED IS A MEDICAL DEVICE MOTUS AZ+ WHICH IS MARKETED IN THE US TERRITORIES WITH 510(K) K211821. IN THE COMMUNICATION RECEIVED BY THE US IMPORTER, CARTESSA, VIA A DEDICATED SERVICE REPORT CASE ID # (B)(4) (AND RELATIVE COMMUNICATION HELD WITH THE SERVICE DEPARTMENT) ARE REPORTED THE FOLLOWING INFORMATION: THE TECHNICIAN REPORTED TO HAVE PERFORMED A SERVICE ON THE DEVICE BECAUSE THE END USER WAS COMPLAINING OF AN INTERNAL TEST ERROR OF THE DEVICE. NO PATIENT OR OPERATOR SERIOUS INJURY HAS BEEN REPORTED. ONCE ARRIVED ON THE SITE THE TECHNICIAN NOTED THE INTERNAL TEST ERROR WHEN ATTEMPTED TO GO FORM THE 'STAND-BY' TO THE 'OPERATE/READY' STATE OF THE DEVICE. THE TECHNICIAN PROCEEDED TO CHECK, WHILE THE DEVICE PERFORMED THE INTERNAL CALIBRATION (AT THE TIME OF THE STATE PASSAGE), IF ANY EMISSION WAS PERFORMED AND FOUND OUT THAT R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18866085 ↗