AMSCO
Received Apr 22, 2026 · Event occurred Mar 23, 2026
Report 3005899764-2026-00031 · MDR key 24956445
Device
Generic name
Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.Model number
AMSCO 600 STEAM STERILIZERCatalog number
EF1101142
Product problems
- Smoking
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE UNIT AND FOUND THE CONTACTOR FOR THE STEAM GENERATOR WAS DAMAGED. THE DAMAGE OBSERVED IS INDICATIVE OF THE CONTACTOR OVERHEATING WHICH LIKELY RESULTED IN THE REPORTED SMOKE. A CAUSE OF THE ISSUE WITH THE CONTACTOR COULD NOT BE DETERMINED. THE ASMCO 600 STEAM STERILIZER IS DESIGNED WITH FLAME-RESISTANT MATERIALS AND IS CERTIFIED BY INTERTEK TO UL 61010-1:2012 3RD ED./CSA C22.2 # 61010-1-12:2012, 3RD ED. SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE, PART 1, AND UL 61010-2-040:2021, 3RD ED/CSA C22.2 # 61010-2-040:2021 3RD ED., SAFETY REQUIREMENTS, PART 2-040 - PARTICULAR REQUIREMENTS FOR STERILIZERS AND WASHER-DISINFECTORS TO TREAT MEDICAL MATERIALS. THE TECHNICIAN REPLACED THE CONTACTOR, TESTED THE UNIT, CONFIRMED IT TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED IT TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.
Description of Event or Problem
THE USER FACILITY REPORTED A SMALL AMOUNT OF SMOKE EMITTED FROM THEIR AMSCO 600 STERILIZER. NO REPORT OF INJURY.