SLT II M094E1Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08057017760009), received between Nov 18, 2016 and Feb 8, 2019 — classified as 2 deaths, 1 malfunction.

The most frequently reported specific device problem is “Output 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.

• DeathFeb 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON JANUARY 21ST, 2019, EL.EN. ELECTRONIC ENGINEERING (B)(4) BECAME AWARE OF AN ADVERSE EVENT, REPORTED BY US IMPORTER, (B)(4), THAT RECEIVED A COMMUNICATION FROM THE BROTHER OF THE PATIENT, CONCERNING THE DEATH OF THE PATIENT 4 DAYS AFTER A TREATMENT WITH SLT II LASER MEDICAL DEVICE. THE PATIENT'S BROTHER REPORTED TO THE US IMPORTER, ON JANUARY THE 17TH, 2019, THAT HER SISTER HAS DIED DUE TO BLEEDING FOLLOWING A TREATMENT WITH THE SLT II LASER MEDICAL DEVICE ON THE THIGHS AREA. WE, THE MANUFACTURER OF THE DEVICE, REQUESTED THE COOPERATION OF OUR US IMPORTER (B)(4) LOCATED IN (B)(4) US, FOR THE INVESTIGATION ON THIS CASE. (B)(4), AT THE TIME OF THE INITIAL COMMUNICATION TO US ALREADY TOOK CHARGE OF THE COMPLAINT AND IMMEDIATELY STARTED ITS OWN INVESTIGATION. (B)(4) ALSO REPRESENTS US DISTRIBUTOR AND SERVICE CENTER FOR EL.EN. ELECTRONIC ENGINEERING (B)(4) MEDICAL DEVICES. (B)(4) IDENTIFIED THE ACTUAL DEVICE INVOLVED IN THE EVENT AS AN SLT II LASER MEDICAL DEVICE SERIAL NUMBER #(B)(4), REF #M094E1 MANUFACTURED BY EL.EN. ELECTRONIC ENGINEERING (B)(4) COMPANY PLACED IN (B)(4). THE ACTUAL INVOLVED MEDICAL DEVICE IS INSTALLED AT (B)(6). (B)(4)'S CLINICAL STAFF PERFORMED THE INVESTIGATION

  Patient problems: Death; Patient Problem/Medical Problem

  MAUDE report 8319889 ↗
• DeathFeb 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT HAD DIED FOLLOWING A LASER PROCEDURE WITH THE SLT II DEVICE.

  Patient problems: Death; Patient Problem/Medical Problem

  MAUDE report 8313178 ↗
• MalfunctionNov 18, 2016Output Problem; Output Problem

  US IMPORTER'S (B)(4) NOTICED US ABOUT A MALFUNCTION THEY RECENTLY BECAME AWARE OF. INVOLVED DEVICE IS CYNOSURE CELLULAZE - SLT II MODEL NUMBER M094A1, S/N (B)(4), MANUFACTURED BY (B)(4). THE ACTUAL DATE OF THE EVENT IS UNKNOWN (BEST ESTIMATE DATE OF THE EVENT (B)(6) 2016) AND EL.EN. SPA BECAME AWARE OF THE EVENT ON OCTOBER 20TH, 2016. EVENT TOOK PLACE IN THE US TERRITORY AT (B)(6). THE USER WAS COMPLAINING THAT THE DEVICE WAS TAKING MORE TIME THAN USUAL TO REACH THE TARGET TEMPERATURE FOR 'PRECISION' LASER TREATMENT OF FACE AND NECK WITH 1440 NM WAVELENGHT TAKING MORE JOULE TO REACH IT. US IMPORTER'S AUTHORIZED SERVICE TECHNICIAN VISITED THE CUSTOMER AND INFORMED US THAT THE SLT II DEVICE, DURING A SERVICE CHECK, FAILS TO MEET SPECIFICATIONS (LOW POWER ENERGY OUTPUT BELOW THE 20% OF TOLERANCE). NO PATIENT INVOLVED AND NO INJURY TO ANY PEOPLE. THIS MALFUNCTION COULD LEAD TO AN UNDER-TREATMENT BUT CANNOT, IN ANY TIME, LEAD TO A SERIOUS INJURY OR DEATH. THAT SAID, ACCORDING TO 'MEDICAL DEVICE REPORTING FOR MANUFACTURER - GUIDANCE FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION STAFF' ISSUED ON NOVEMBER 8TH, 2016, AT CHAPTER 2.14, THIS MALFUNCTION IS NOT REPORTABLE. WE, THE MANUFACTURER,

  Patient problems: No Patient Involvement

  MAUDE report 6112772 ↗