{ "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": "216219", "product_res_number": "Z-0167-2026", "event_date_initiated": "2025-09-05", "event_date_posted": "2025-10-16", "recall_status": "Open, Classified", "res_event_number": "97616", "product_code": "MHX", "k_numbers": [ "K112962", "K120616" ], "product_description": "Brand Name: Branding is not applied to this product.\nProduct Name: DVI display cables\nModel/Catalog Number: 012-0895-01\nSoftware Version: N/A\nProduct Description: 6 foot DVI-I to DVI-I male/male display cable.\nComponent: Yes, the cable is an external display cable used with the 91390 and 91393", "code_info": "Lot Code: UDI-DI for products that are used with the display cables. (01)10841522131479 (Xprezzon),\n(01)10841522131455 (Qube)", "firm_fei_number": "3010157426", "recalling_firm": "Spacelabs Healthcare, Inc.", "address_1": "35301 Se Center St", "city": "Snoqualmie", "state": "WA", "postal_code": "98065-9216", "additional_info_contact": "Zachary Orlowski\n+1-425-3963300", "reason_for_recall": "Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient's safety by interfering with the operation of another electronically sensitive medical device are in use.", "root_cause_description": "Device Design", "action": "On 09/05/2025, the firm email an \"URGENT MEDICAL DEVICE CORRECTION\" Letter to customer informing them that the DVI cables which are used for connecting the Qube (91390) or Xprezzon (91393) to the 94267-19, 94267-L19, 94267-L17 and 94267-L15 displays, do not meet the EMI/EMC electrical safety standards specifically for electromagnetic shielding and may pose serious risks to patient safety by interfering with the operation of another device, particularly in environments where electrically sensitive medical devices are in use.\n\nCustomers are instructed to acknowledge receipt and understanding of this notification and request replacement cables as soon as possible, however no later than 31-Dec-2025.\nDo not replace cables while a patient is admitted to the monitor to mitigate any potential disruption in active patient monitoring. Any affected cables not currently in use should not be placed into service.\n\nFor questions and/or assistance with this recall, contact:\nSpacelabs Technical Support\nSpacelabs Healthcare, Inc\n35301 SE Center Street\nSnoqualmie, WA 98065\n1-800-522-7025 and select 2 for Technical Support\nEmail: Support@spacelabs.com", "product_quantity": "8179", "distribution_pattern": "Worldwide - United States Nationwide distribution including in the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, VA, WA, WI, WY and the countries of AFG, ARE, ARG, AUS, AUT, BGD, BHR, BOL, BRA, BRN, CAN, CHE, CHL, CHN, COL, CRI, CYP, CZE, DOM, DZA, ECU, EGY, ESP, FRA, GBR, GRC, GTM, GUM, HKG, IDN, IND, IRL, IRN, ISR, ITA, JOR, KWT, LBN, MAR, MEX, MYS, NLD, NZL, OMN, PAK, PAN, PER, PHL, PLS, POL, PRI, PRT, PRY, QAT, ROM, SAU, SGP, SLV, SRB, THA, TTO, TUN, TUR, TWN, VNM.", "openfda": { "k_number": 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"3005521864", "3010703925", "3003971136" ], "device_name": "Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1025", "device_class": "2" } } ] }