{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "53494",
      "product_res_number": "Z-0325-2008",
      "event_date_initiated": "2007-06-27",
      "event_date_posted": "2008-01-17",
      "recall_status": "Terminated",
      "event_date_terminated": "2010-10-20",
      "res_event_number": "38368",
      "product_code": "M",
      "k_numbers": [
        "K060919"
      ],
      "product_description": "Actical with Step, Part Number 198-0302-00, Mini Mitter, a Respironics Company, Bend, Oregon",
      "code_info": "Serial Numbers: B100001, B100002, B100003, B100005, B100006, B100007, B100008, B100009, B100023, B100024, B100025, B100026, B100027, B100028, B100029, B100030, B100031, B100032, B100033, B100034, B100035, B100036, B100037, B100038, B100039, B100041, B100042, B100043, B100044, B100045, B100046, B100047, B100048, B100049, B100050, B100051, B100052, B100053, B100054, B100055, B100056, B100057, B100058, B100059, B100060, B100061, B100062, B100063, B100064, B100065, B100066, B100067, B100068, B100069, B100070, B100071, B100072, B100073, B100074, B100075, B100076, B100077, B100078, B100079, B100080, B100081, B100082, B100083, B100084, B100085, B100086, B100087, B100088, B100089, B100090, B100091, B100092, B100093, B100094, B100095, B100096, B100097, B100098, B100099, B100100, B100101, B100102, B100103, B100104, B100105, B100106, B100107, B100108, B100109, B100110, B100111, B100112, B100113, B100114, B100115, B100116, B100117, B100118, B100119, B100120, B100121, B100122, B100123, B100124, B100125, B100126, B100127, B100128, B100129, B100130, B100131, B100132, B100133, B100134, B100135, B100136, B100137, B100138, B100139, B100140, B100141, B100142, B100143, B100144, B100145, B100146, B100147, B100148, B100149, B100150, B100151, B100152, B100153, B100154, B100155, B100156, B100157, B100158, B100159, B100160, B100161, B100162, B100163, B100164, B100165, B100166, B100167, B100168, B100169, B100170, B100171, B100172, B100173, B100174, B100175, B100176, B100177, B100178, B100179, B100180, B100181, B100182, B100183, B100184, B100185, B100186, B100187, B100188, B100189, B100190, B100191, B100192, B100193, B100194, B100195, B100196, B100197, B100198, B100199, B100200, B100201, B100202, B100203, B100204, B100205, B100206, B100207, B100208, B100209, B100210, B100211, B100212, B100213, B100214, B100215, B100216, B100217, B100218, B100219, B100220, B100221, B100222, B100223, B100224, B100225, B100226, B100227, B100228, B100229, B100230, B100231, B100232, B100233, B100234, B100235, B100236, B100237, B100238, B100239, B100240, B100241, B100242, B100243, B100244, B100245, B100246, B100247, B100248, B100249, B100250, B100251, B100252, B100253, B100254, B100255, B100256, B100257, B100258, B100259, B100260, B100261, B100262, B100263, B100264, B100265, B100266, B100267, B100268, B100269, B100270, B100271, B100272, B100273, B100274, B100275, B100276, B100277, B100278, B100279, B100280, B100281, B100282, B100283, B100284, B100285, B100286, B100287, B100288, B100289, B100290, B100291, B100292, B100293, B100294, B100295, B100296, B100297, B100298, B100299, B100300, B100301, B100302, B100303, B100304, B100305, B100306, B100307, B100308, B100309, B100310, B100311, B100312, B100313, B100314, B100315, B100316, B100317, B100318, B100319, B100320, B100321, B100322, B100323, B100324, B100325, B100326, B100327, B100328, B100329, B100330, B100331, B100332, B100333, B100334, B100335, B100336, B100337, B100338, B100339, B100340, B100341, B100342, B100343, B100344, B100345, B100346, B100347, B100348, B100349, B100350, B100351, B100352, B100353, B100354, B100355, B100356, B100357, B100358, B100359, B100360, B100361, B100362, B100363, B100364, B100365, B100366, B100367, B100368, B100369, B100370, B100371, B100372, B100373, B100374, B100375, B100376, B100377, B100378, B100379, B100380, B100381, B100382, B100383, B100384, B100385, B100386, B100387, B100388, B100389, B100390, B100391, B100392, B100393, B100394, B100395, B100396, B100397, B100398, B100399, B100400, B100401, B100402, B100403, B100406, B100407, B100408, B100409, B100410, B100411, B100412, B100413, B100414, B100415, B100416, B100417, B100418, B100419, and B100420",
      "firm_fei_number": "3007223238",
      "recalling_firm": "Mini-Mitter Company, Inc.",
      "address_1": "20300 Empire Ave Ste B3 20300 Empire Ave",
      "address_2": "Ste B3",
      "city": "Bend",
      "state": "OR",
      "postal_code": "97701",
      "additional_info_contact": "Frederic Viaud\n724-387-7919",
      "reason_for_recall": "Communication Failure:  the devices have a memory chip that has a limited number of read/write cycles which can trigger set up information and/or subject information anomalies or intermittent communication annomalies. If left unaddressed, the issues can lead to permanent communication failure.",
      "root_cause_description": "Software design",
      "action": "A Voluntary Medical Device Recall letter dated June 26, 2007. The recall letter will instruct the customers to 1) fill out a business reply form to confirm contact information and devices serial numbers in their possession.  Then FAX this info back immediately to Stericycle or Mini-Mitter. 2) Refer to the work scheduled rework date reserved for them and noted in their recall notification letter and return the device for service at that time; and 3) Package the device appropriately, insure it and return it via UPS using the provided UPS shipping label. Product returned to Mini-Mitter will be quarantined, decontaminated, and repaired.  Min-Mitter will rework all the devices returned.  Each will have a new memory chip installed, be re-calibrated, retested, and have a new battery installed if required.  Min-Mitter will provide a new one year warranty.",
      "product_quantity": "403",
      "distribution_pattern": "Worldwide",
      "openfda": {}
    }
  ]
}