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AMSCO

Corporation Steris Canada · Model 1215 · UDI-DI 00724995214432

MEC
2
510(k) clearances
1,315
Adverse events
31
Recalls
40
Facilities

Description

AMSCO 1215 Cart and Utensil Washer/Disinfector, 600V, 60hz, Electric Heated has a small footprint that maximizes experiences by significantly reducing manual cleaning of case carts and containers.

Recalls

DateFirmReason
2025-11-19Steris CorporationWire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal within the unit (no risk of s
2025-11-19Steris CorporationWire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal within the unit (no risk of s
2025-08-29Getinge Disinfection AbPotential for device to overheat during operation if the circulation pressure calibration was not performed or had been performed incorrectly, and the low-pressure alarm is not tri
2025-04-02Getinge Disinfection AbThe frequency inverter is not programmed by supplier according to specification which causes the circulation pump to start earlier than expected, resulting in additional wear and t
2025-04-02Getinge Disinfection AbThe frequency inverter is not programmed by supplier according to specification which causes the circulation pump to start earlier than expected, resulting in additional wear and t
2023-04-10Steris CorporationIn the remote occurrence in which the electrical contactor component present in the drying chambers of the Reliance Vision Multi-Chamber Washer/Disinfector malfunctions, the heatin
2022-04-22Steris CorporationThe firm identified that when the electrical contactor component in the drying chamber of the Washer/Disinfector malfunctions, the heating elements in the drying chamber could over
2022-04-13Getinge Usa Sales IncVerification of installation not documented or may be incomplete, could result in harm to the user such as skin burns, smoke inhalation, electric shock, or a crush or pinch injury
2022-04-13Getinge Usa Sales IncVerification of installation not documented or may be incomplete, could result in harm to the user such as skin burns, smoke inhalation, electric shock, or a crush or pinch injury
2022-04-01Getinge Usa Sales IncInadequate documentation verifying whether device installation has been executed in accordance with the manufacturer's requirements. This can lead to installation failure modes and

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.