{ "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": "123184", "product_res_number": "Z-0351-2014", "event_date_initiated": "2013-10-17", "event_date_posted": "2013-11-18", "recall_status": "Terminated", "event_date_terminated": "2014-04-02", "res_event_number": "66727", "product_code": "MHX", "k_numbers": [ "K120616" ], "product_description": "Spacelabs Healthcare qube Compact Patient Monitor, Model 91390. It is a patient monitor with arrhythmia detection or alarms.\n\nThe qube is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment. These devices determine a) when an alarm condition is violated; b) the alarm priority (i.e. high, medium or low); c) alarm limits; and d) when to initiate and terminate alarm notifications.", "code_info": "SERIAL NUMBERS IN THE US:  1390-101940, 1390-101945, 1390-101946, 1390-101947, 1390-101948, 1390-101950, 1390-101951, 1390-101952, 1390-101953, 1390-101954, 1390-101955, 1390-101956, 1390-101957, 1390-101958, 1390-101962, 1390-101963, 1390-101971, 1390-101972, 1390-101973, 1390-101974, 1390-101979, 1390-101980, 1390-101994, 1390-102002, 1390-102003, 1390-102004, 1390-102005, 1390-102006, 1390-102007, 1390-102008, 1390-102009, 1390-102010, 1390-102011, 1390-102012, 1390-102013, 1390-102014, 1390-102015, 1390-102016, 1390-102017, 1390-102018, 1390-102019, and 1390-102020.   SERIAL NUMBER INTERNATIONAL:  1390-101949, 1390-101969, 1390-101970, 1390-101975, 1390-101976,  1390-101977, 1390-101978, 1390-102001, 1390-102021, 1390-102022,  1390-102023, and 1390-102024.", "firm_fei_number": "3010157426", "recalling_firm": "Spacelabs Healthcare, Llc", "address_1": "35301 Se Center St", "city": "Snoqualmie", "state": "WA", "postal_code": "98065-9216", "additional_info_contact": "800-522-7025", "reason_for_recall": "Spacelabs Healthcare qube Compact Patient Monitor, Model 91390, may fail to power ON due to incorrect programmed microcontroller component.", "root_cause_description": "Nonconforming Material/Component", "action": "Spacelabs Healthcare sent the \"URGENT -MEDICAL DEVICE CORRECTION Spacelabs Healthcare qube Compact Monitor\" letter, dated 01 November 2013, to the US consignees/customers on November 1, 2013. Spacelabs Healthcare will send the customer letter (translated as necessary) to all international subsidiaries and distributors of record via email on November 6, 2013. The letter described the product, problem and actions to be taken. The customers were instructed to advise staff of the potential for the monitor to fail to turn ON.\n\nSpacelabs Healthcare will contact their customers at the earliest possible date to schedule a convenient time for Spacelabs to correct all of your facility's affected monitors at no cost. \n\nIf you have any questions about this corrective action program, please contact Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support.", "product_quantity": "54 units total (42 units in the US and 12 outside US)", "distribution_pattern": "Worldwide distribution: US (nationwide) including states of: Georgia, Idaho, New York, Oklahoma, Tennessee, Texas, and Wyoming and in countries of: Bahrain, Canada, France, Great Britain, Poland, and The Netherlands.", "openfda": { "k_number": [ "K014213", "K992273", "K062098", "K050742", "K152902", "K023698", "K173036", "K092369", "K081793", "K043551", "K123472", "K024108", "K130584", "K113657", "K192514", "K221904", "K923054", "K023674", 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"2" } } ] }