Events

Device Recall Olympic Pasteurmatic 3000; Olympic Pasteurmatic 3500 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Natus Medical Incorporated 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    76427
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2701-2017
  • 사례 시작날짜
    2017-05-22
  • 사례 출판 날짜
    2017-06-02
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153196
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Disinfector, medical devices - Product Code MEC
  • 원인
    Olympic pasteurmatic 3000/3500 systems are recalled because they do not fully meet todays regulatory requirements. given the age of the products design, component and technology obsolescence, and the time involved in fully complying with the latest design and development standards, the firm decided to recall of the olympic pasteurmatic 3000/3500 system devices by means of disabling the devices.
  • 조치
    Natus Medical sent an URGENT: RECALL NOTIFICATION MEDICAL DEVICE RECALL letter dated May 2017. Please refer to the accompanying Instructions to Disable the Pasteurmatic (DOC-022838), then complete and return the attached reply form. Should you require assistance in decommissioning your affected system please indicate option 2 on the reply form and you will be contacted to schedule an in- service. Natus may reimburse facilities for Olympic Pasteurmatic" 3000/3500 System purchases based on the age of the affected system as determined by the system serial number. There is no evidence to suggest there is a safety risk associated with the Olympic Pasteurmatic" 3000/3500 System device, nor have there been any safety incidences reported to Natus. Natus apologizes for any inconvenience. Please understand that this is part of our commitment to providing only the highest quality products and information to our customers. Please contact us at Natus_Quality_Programs@natus.com or (866) 940-7143 option #2 if you have any further questions.

Device

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
    General Hospital and Personal Use Devices
  • 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
    Natus Medical Incorporated

Manufacturer

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