DEKA Motus AX M112B1Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08057017760221), received between Jun 26, 2018 and Feb 9, 2021 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, EL.EN. ELECTRONIC ENGINEERING SPA BECAME AWARE OF AN ADVERSE EVENT, REPORTED BY THE PATIENT VIA EMAIL, CONCERNING AN ADVERSE EVENT HAPPENED TO HER FOLLOWING A HAIR REMOVAL TREATMENT WITH MOTUS AX LASER MEDICAL DEVICE AND ND:YAG LASER SOURCE. THE PATIENT REPORTED IN HER EMAIL THAT SHE HAS RECENTLY GOT ( WITHOUT SPECIFYING THE EXACT DATE OF THE EVENT) A HAIR REMOVAL TREATMENT IN THE UNDERARM, BIKINI AND PERINEAL AREAS AND TO HAVE DEVELOPED BURNS. THE PATIENT, IN HER NARRATIVE, REPORTED THAT SHE HAD ALREADY USED THE ND:YAG LASER FOR A YEAR, AND NEEDED A FEW TOUCH-UPS. THE CLINIC PRACTITIONER SUGGESTED THE PATIENT A CYCLE OF 3 TREATMENTS WITH THE MOTUS AX. DURING THE TREATMENT (NOT SPECIFIED WHICH ONE OF THE THREE SCHEDULED) THE PATIENT EXPERIENCED STRONG PAIN AND BURNING SENSATION. FOR THE FOLLOWING TWO HOURS, POST TREATMENT, SHE WAS UNABLE TO PROPERLY SIT AND WALK. THE PRACTITIONER AND THE NURSE WHO ACTUALLY PERFORMED THE TREATMENT, RECOMMENDED THE PATIENT TO APPLY ALOE VERA ON THE AREA. DESPITE THE ALOE VERA THE FOLLOWING DAY THE PATIENT DEVELOPED BLACK WELTS IN THE TREATED AREA. IN THE FOLLOWING DAYS THE PATIENT DEVELOPED PAINFUL BLISTERS IN THE TREATED AREA. THE PA

  Patient problems: Blister; Burn(s)

  MAUDE report 11299914 ↗
• InjuryJun 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN DATE (B)(6) 2018 EL.EN.'S US AGENT, MR. (B)(6), RECEIVED A COMMUNICATION FROM FDA RELATIVE TO A VOLUNTARY MEDWATCH REPORT CODE MW5077152. THE SAME DAY MR. (B)(6) FORWARDED THE MAIL TO EL.EN. AS THE MANUFACTURER OF THE DEVICE INVOLVED IN THE ADVERSE EVENT REPORTED IN THE VOLUNTARY MEDWATCH REPORT MW5077152. THE PATIENT , MS. (B)(6), REPORTED TO HAVE RECEIVED A TREATMENT WITH THE MOTUS AX LASER MEDICAL DEVICE (REF: (B)(4) - S/N: (B)(4)- CDRH ACCESSION NUMBER: (B)(4)- MANUFACTURED BY EL.EN. ELECTRONIC ENGINEERING (B)(4)) FOR HAIR REMOVAL IN THE LOWER FACE AND NECK AREA. SHE STATES THAT THE TREATMENT WAS PERFORMED BY THE LASER TECHNICIAN WITH THE LOWEST SETTINGS RECOMMENDED BY THE MANUFACTURER FOR HER SKIN TYPE. MS. (B)(6) REPORTS IN THE MEDWATCH REPORT TO HAVE SUFFERED EXTREME BURNS, PAIN, DISFIGURATION AND SCARRING. THE DATE OF THE EVENT REPORTED BY MS. (B)(6) IS (B)(6) 2018 WHILE THE MEDWATCH REPORT MW5077152 HAS BEEN SENT TO THE FDA IN DATE (B)(6) 2018 AND RECEIVED BY FDA IN DATE (B)(6) 2018. THE CONTACT DETAIL OF MS. (B)(6), REPORTED IN THE MEDWATCH REPORT ARE THE EMAIL AND PHONE NUMBER (STATED IN SECTION OF THE PRESENT MDR REPORT). THIS MEDWATCH REPORT IS IN RESPONSE TO FDA RE

  Patient problems: Burn(s); Pain; Scar Tissue

  MAUDE report 7636948 ↗