BEUDAMED
    49 results · 14ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Recall × Status: Terminated × Clear all

    Cidexplus Solution Test Strips

    FDA Recall
    Terminated ·Advanced Sterilization Products·Product code JOJ·March 16, 2005

    Cidex Plus Test Strips

    FDA Recall
    Terminated ·Advanced Sterilization Products·Product code JOJ·December 17, 2003

    Axiom Artis systems. C-arm angiographic x-ray system x-ray, angiographic system.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IZI·April 26, 2013

    Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-502 Product Usage: Used in facilities such as Central Sterile Supply Departments, next to the Operating Room, in dental clinics or hospital wards to clean, thermally or chemically disinfect and dry surgical goods.

    FDA Recall
    Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code MEC·January 16, 2020

    Getinge AGS, FSLC, FSUC, RC accessory to Washer- Disinfector 86 Series UDI Info: 86 Series Washer Disinfector 07340153700246, 07340153700253, 07340153700260, 07340153700277 Getinge automated loading/unloading systems are intended to be used as an automatic conveyor/transport system for unloading carriers (wash carts) from Getinge 86/88 series Washer-disinfectors. The automated loading/unloading systems in no way affect the cleaning/disinfection performance of the washer-disinfector. The automated loading/unloading equipment is considered an accessory to the medical washer-disinfector.

    FDA Recall
    Terminated ·Getinge Disinfection Ab Ljungadalsgatan·Product code MEC·March 2, 2018

    Reliance Vision Single-Chamber Washer/Disinfector - Product Usage: intended for use in the cleaning and intermediate level disinfection of soiled reusable utensils, trays, glassware, bedpans and urinals, rubber and plastic goods, simple hard-surfaced rigid surgical instruments, such as forceps and clamps, theatre shoes, and other similar and related articles found in healthcare facilities.

    FDA Recall
    Terminated ·Steris Corporation·Product code MEC·December 11, 2020

    Model 8666 Washer/Disinfector with holding tank heater option. Firm on label is Getinge Disinfection AB, Vaxjo, Sweden.

    FDA Recall
    Terminated ·Getinge/Castle, Inc.·Product code MEC·March 25, 2003

    Getinge 88-Series-washer disinfectors intended for cleaning, disinfection and drying Model Number: 88-5 Part Number: 88-103; 88-203

    FDA Recall
    Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code MEC·February 10, 2020

    Reliance 1227 Cart and Utensil Washer/Disinfector Product Usage: Usage: The Reliance 1227 Cart and Utensil Washer/Disinfector is intended for use in the cleaning and low-level disinfection of bedpans and urinals, basins, carts, beds, theater shoes and other miscellaneous reusable items used in the care of patients.

    FDA Recall
    Terminated ·Steris Corporation·Product code MEC·June 30, 2014

    Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86662003 Product Usage: Usage: The Getinge 86 Series Medical Washer-Disinfector is designed for use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.

    FDA Recall
    Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code MEC·May 20, 2019

    Reliance Synergy Washer/Disinfector

    FDA Recall
    Terminated ·Steris Corporation·Product code MEC·April 22, 2022

    Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86682003 Product Usage: The Getinge 86 Series Medical Washer-Disinfector is designed for use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.

    FDA Recall
    Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code MEC·May 20, 2019

    The Reliance 130 and 130L Cart Washer/Disinfector is a high capacity mechanical washer intended for use in the washing, low-level disinfecting, and drying of carts, utensils, beds and other miscellaneous reusable items used in the care of patients at healthcare facilities / Crated for shipping.

    FDA Recall
    Terminated ·Steris Corporation·Product code MEC·July 14, 2012

    Getinge brand --- large capacity, floor loading jet spray, washers for mechanical washing, intermediate level, thermal disinfection and drying of moisture and temperature stable Hospital case carts, sterilization containers, material handling carts, stands and utensils. --- Model numbers Getinge 9120, 9122, 9125, and 9128

    FDA Recall
    Terminated ·Getinge USA Inc·Product code MEC·May 25, 2012

    GETINGE 46-SERIES Medical Washer-Disinfector, Models 46-4 and 46-5, with PACS 300/350 Control Series with dryer --- Class II, exempt from 510(k) requirements. For use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.

    FDA Recall
    Terminated ·Getinge Disinfection Ab Ljungadalsgatan·Product code MEC·November 26, 2014

    AMSCO 5000 Series Washer/Disinfector Model # 5052

    FDA Recall
    Terminated ·Steris Corporation·Product code MEC·December 20, 2018

    Reliance Vision Single Chamber Washer/Disinfector, Model # 1802983, The Vision Single Chamber Washer is intended for use in the cleaning and intermediate level disinfection of soiled reusable utensils, trays, glassware, bedpans and urinals, rubber and plastic goods, simple hard-surfaced rigid surgical instruments such as forceps and clamps, theatre shoes and other similar and related articles found in healthcare facilities.

    FDA Recall
    Terminated ·Steris Corporation·Product code MEC·May 9, 2011

    AMSCO 3000 Series Washer/Disinfector Model # 3052

    FDA Recall
    Terminated ·Steris Corporation·Product code MEC·December 20, 2018

    The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are intended for cleaning and high-level disinfection of respiratory therapy and anesthesia equipment by killing vegetative bacteria and viruses, in a hot water bath at ~160 - ~170 F for 30 minutes. Catalog Number/Description: 007168 PM3500 ASSY (15KW 208/120V) 007169 PM3000 ASSY (9KW 208/120V) 007169R PM3 (9KW 208/120) REFURB 007170 PM3 ASSY (8.3KW 200V DELTA) 007171 PM3 ASSY (9KW 220V SING PH) 52640 PASTEURMATIC 3000 W/O BASKETS 52640R PM 3000 w/o Baskets Refurb 52640-200 PM 3000 W/O BASKETS 200V 52640-220 PM 3000 W/O BASKETS 220V 52641 PASTEURMATIC 3000 W/BASKET S 52641R PM 3000 w/ Baskets Refurb 52641-200 PM 3000 W BASKETS 200V 52641-220 PM 3000 W/ BASKETS 220V 52650 PASTEURMATIC 3500 W/O BASKET 52651 PASTEURMATIC 3500 W/BASKETS S

    FDA Recall
    Terminated ·Natus Medical Incorporated·Product code MEC·May 22, 2017

    Reliance 1227 Cart and Utensil Washer/Disinfector, FW03101, FW03102, FW03S003 Product Usage: The Reliance 1227 Cart and Utensil Washer/Disinfector is intended for use in the cleaning and low-level disinfection of bedpans and urinals, basins, carts, beds, theatre shoes and other miscellaneous reusable items used in the care of patients.

    FDA Recall
    Terminated ·Steris Corporation·Product code MEC·May 23, 2018