{ "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. 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"recalling_firm": "Spacelabs Healthcare, Inc.", "address_1": "35301 Se Center St", "city": "Snoqualmie", "state": "WA", "postal_code": "98065-9216", "additional_info_contact": "Brad Chen\n425-396-3300", "reason_for_recall": "Multi-parameter command module has a circuit board issue and when in Auto mode, Cardiac Output (CO) measurement may activate early, resulting in Bad Curve error with no CO measurement or Irregular Curve error with CO measurement not automatically excluded, which may result in inaccurate readings, or the need of additional readings, which may lead to delayed care and/or fluid overload.", "root_cause_description": "Component change control", "action": "On 2/27/2026, correction notices were emailed to customers who were asked to do the following:\n1. Notify all relevant employees within your organization. If products were further distributed, please forward the notice to these sites/customers.\n2. Complete and return the acknowledgement form via email to: Installedbase@Spacelabs.com \n3. Instruct staff who utilize the cardiac output feature to use the \"Manual\" mode, or use a non-impacted module in its place (if available) until the impacted module has been corrected.\n4. Contact your local Spacelabs Healthcare service and support representative to schedule your device correction as soon as possible.\n\nFirm's Support Contact:\nPhone: 1-800-522-7025\nEmail: Support@Spacelabs.com Website: https://spacelabshealthcare.com/support/", "product_quantity": "1790", "distribution_pattern": "Worldwide - US Nationwide distribution including in the states of NY, NJ, AL, OK, IA, MT, WY, MN, TX, WI, PA, WA, OR, MI, CA, SC, ID, FL, MS, KS, SD, LA, OH, MO, NH, GA, MD, TN, AZ, PR and the countries of TAIWAN, CANADA, KUWAIT, FRANCE, SAUDI ARABIA, POLAND, PAKISTAN, MEXICO, ARGENTINA, PANAMA.", "openfda": { "k_number": [ "K860078", "K860834", "K980186", "K830029", "K913576", "K974792", "K830163", "K891148", "K071889", "K182532", "K830306", "K982697", "K895266", "K803282", "K012336", "K153473", "K864506", "K071655", "K844791", "K880505", "K942147", "K012241", "K082633", "K970348", "K152550", "K974698", "K781911", "K020550", "K960884", "K896862", "K011824", "K053263", 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