{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "221162", "product_res_number": "Z-2916-2026", "event_date_initiated": "2026-06-04", "event_date_posted": "2026-08-07", "recall_status": "Open, Classified", "res_event_number": "99260", "product_code": "MHX", "k_numbers": [ "K122146" ], "product_description": "Brand Name: Xhibit\nProduct Name: Xhibit Central Station\nModel/Catalog Number: 96102\nSoftware Version: N/A\nProduct Description: The Spacelabs Healthcare (Spacelabs) Xhibit Central Station, Model 96102. Xhibit offers remote surveillance of patient data for those patients connected to a Spacelabs Healthcare bedside monitors and telemetry systems. The DisplayPort audio/video splitter allows users to extend the audio/video source from the Xhibit to additional external displays or monitors. This extension of audio/video is for viewing only and does not allow interaction with the Xhibit.\nComponent: The DisplayPort audio/video splitter is a 3rd party external accessory to Xhibit.", "code_info": "Model/Catalog Number: 96102\nDisplayPort Splitter Part Number: 010-1975-00\nUDI-DI codes:\n1084152212706\n10841522100345\nSerial Numbers: Pending", "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": "Brad Chen\n+1-425-3963300", "reason_for_recall": "Due to off-the-shelf display port component that has audio/video failures", "root_cause_description": "Unknown/Undetermined by firm", "action": "On 06/04/2026, an \"URGENT MEDICAL DEVICE CORRECTION\" Letter was emailed to customers informing them that the use of DisplayPort Splitter (PN 010-1975-00) may potentially result in a loss of audio, video, or both audio and video at the local Xhibit Central Station and/or extended displays.\n\nCustomers are instructed to:\n1. Discontinue use Discontinue use of the DisplayPort Splitter, Model number 010-1975-00, or any unapproved splitters that may be used.\n2. Notify Inform all relevant personnel within your organization, including any facilities to which you have distributed the affected products.\n3. Acknowledge Confirm receipt of this notification by scanning the QR code below and completing the form. Include the model number of splitter that is utilized at the facility, and if it was purchased through Spacelabs Healthcare. (PDF version of the acknowledgement form can be provided upon request)\n4. Disposal Dispose of all affected components.\n5. Replace Replace the affected DisplayPort Splitters following the proper installation requirements outlined in section 6 and 7 of CSN 077-0722-00.\n6. Fill out the Customer Response Form using the link or QR code provided below. Spacelabs has partnered with IQVIA MedTech to coordinate the recall response process.\n\" Link: https://iqvia-response.my.site.com/mt/fca?cid=spacelabsxhibit-av\n\nFor questions or support - contact Customer Support at 1-800-522-7025 or via website https://spacelabshealthcare.com/support/", "product_quantity": "6074", "distribution_pattern": "Worldwide - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, VA, WA, WI, WY and the countries of CANADA, FRANCE, ITALY, MALAYSIA, THAILAND.", "openfda": { "k_number": [ "K130849", "K081891", "K082045", "K220308", "K143676", "K150082", "K151860", "K132075", "K190011", "K011000", "K000815", "K022889", "K102040", "K033304", "K040395", "K223498", "K012915", "K251702", "K945385", "K073462", "K160981", "K132533", "K023569", "K173036", "K100939", "K081983", "K923054", "K000854", "K990563", 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