Device Recall Olympic Pasteurmatic 3000; Olympic Pasteurmatic 3500

  • 모델명 / 제조번호(시리얼번호)
    ************Serial numbers of affected units distributed to US government***************  3056 and 9199.  ************Serial numbers of affected units distributed to US consignees***************  3039, 3041, 3043, 3045, 3050, 3055, 3062, 3071, 3079, 3083, 3084, 3096, 3100, 3113, 3143, 3153, 3155, 3162, 3165, 3174, 3188, 3192, 3194, 3195, 3223, 3224, 3229, 3232, 3238, 3240, 3249, 3260, 3265, 9197, 9198, 03003, 03004, 03012, 03020, 03022, 03028, 03034, 03047, 3002, 3006, 3009, 3013, 3029, 3035, 3044, 3046, 3047, 3048, 3052, 3059, 3063, 3084, 3085, 3091, 3091, 3094, 3099, 3101, 3110, 3118, 3134, 3136, 3142, 3145, 3148, 3149, 3156, 3161, 3169, 3171, 3173, 3180, 3181, 3183, 3185, 3189, 3190, 3198, 3225, 3227, 3237, 3239, 3241, 3266, 3277, 3278, 3279, 3281, 3345, and 9198.   ************Serial numbers of affected units distributed to international consignees*******  3019, 3036, 3040, 3049, 3051, 3053, 3054, 3057, 3061, 3064, 3065, 3067, 3072, 3073, 3074, 3077, 3078, 3080, 3081, 3082, 3083, 3084, 3086, 3087, 3088, 3089, 3090, 3092, 3093, 3097, 3098, 3102, 3103, 3104, 3106, 3107, 3109, 3113, 3116, 3117, 3120, 3123, 3124, 3129, 3130, 3131, 3132, 3135, 3137, 3138, 3139, 3144, 3146, 3147, 3150, 3151, 3152, 3154, 3158, 3163, 3164, 3166, 3167, 3172, 3172, 3175, 3177, 3178, 3179, 3182, 3186, 3187, 3193, 3196, 3204, 3206, 3208, 3210, 3211, 3211, 3215, 3217, 3218, 3219, 3220, 3221, 3222, 3226, 3228, 3230, 3231, 3233, 3234, 3235, 3242, 3243, 3244, 3245, 3246, 3247, 3250, 3251, 3252, 3253, 3254, 3257, 3261, 3264, 3267, 3268, 3269, 3270, 3272, 3273, 3274, 3276, 3280, 03008, 03014, 03017, 03018, 03021, 03023, 03024, 03027, 03175, 03200, 3025, 3035, 3037, 3058, 3060, 3068, 3070, 3075, 3076, 3095, 3105, 3108, 3111, 3114, 3115, 3119, 3121, 3122, 3125, 3126, 3128, 3133, 3140, 3141, 3157, 3159, 3160, 3168, 3170, 3176, 3184, 3191, 3200, 3201, 3202, 3203, 3205, 3207, 3209, 3212, 3213, 3214, 3216, 3236, 3248, 3258, 3259, 3262, 3271, 3275, and 9200.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) Distribution to the states of : AL, AR, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NH, NJ, NM, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI, and WV and in the following countries: Canada, Colombia, Costa Rica, Ecuador, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, Mexico, Panama, Peru, Qatar, Saudi Arabia, Taiwan, Thailand, and Viet Nam.
  • 제품 설명
    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
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Natus Medical Incorporated, 5900 1st Ave S, Seattle WA 98108-3248
  • 제조사 모회사 (2017)
  • Source
    USFDA