{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "183711", "product_res_number": "Z-0109-2021", "event_date_initiated": "2020-03-10", "event_date_created": "2020-10-15", "recall_status": "Terminated", "event_date_terminated": "2021-06-01", "res_event_number": "86439", "product_code": "LMD", "product_description": "SkyVision SDS System - Video Integration\nModel: GC-SDS-BSCB-200 - Product Usage: is a high quality, self-contained video switching and control unit for use in the operating room.", "code_info": "Serial Numbers: DIPSG212460015 DIPSG212510043 DIPSG213160042 DIPSG214480117 DIPSG215040016 DIPSG219380004 DIPSG219380005 DIPSG219380006 DIPSG219380007 DIPSG219380008 DIPSG219380013 DIPSG219380014 DIPSG219380015 DIPSG219380016 DIPSG219380017 DIPSG219380018 DIPSG219380019 DIPSG219380020 DIPSG219380021 DIPSG219380022 DIPSG219380023 DIPSG219380024 DIPSG219380025 DIPSG219380026 DIPSG219420002 DIPSG219420003 DIPSG219420004 DIPSG219420005 DIPSG219420006 DIPSG219420007 DIPSG219470004 DIPSG219470008 DIPSG219470011 DIPSG219470013 DIPSG219470014 DIPSG219490014", "firm_fei_number": "1825014", "recalling_firm": "Skytron, Div. The KMW Group, Inc", "address_1": "5085 Corporate Exchange Blvd SE", "city": "Grand Rapids", "state": "MI", "postal_code": "49512-5515", "additional_info_contact": "SAME\n616-656-2900", "reason_for_recall": "Intermittent failure of a signal being sent to a monitor from the touch panel display causing the displaying monitor to go Blank and the touch panel to display a Blank image when reviewing the target display. If this issue were to happen during a case, cause increase risk to patient due to hospital losing the visual image.", "root_cause_description": "Software Manufacturing/Software Deployment", "action": "Skytron Authorized Representatives contacted the affected facilities beginning on 3/4/20 via phone or in person .Skytron Authorized Representatives visited sites to correct the issue wih the following message:\n Skytron, LLC is voluntarily recalling a limited number of SDS integration units. The SDS router may experience an intermittent issue related to display output functionality. This failure poses a potential safety risk to patients. This firmware update is being conducted to correct the failure.", "product_quantity": "36 units", "distribution_pattern": "US Nationwide distribution including in the states of CA, FL, IA, MI, MN, NY, PA, TX, WA.", "openfda": { "k_number": [ "K970064", "K933103", "K974130", "K970652", "K943158", "K926315", "K954479", "K953163", "K933098", "K952914", "K941203", "K961689", "K954567", "K962699", "K965161", "K954071", "K950413", "K940408", "K971153", "K974255", "K936116", "K980241", "K944771", "K970293", "K974882", "K911773", "K974102", "K953398", "K900227", "K920268", "K954008", "K973239", "K971154", "K923582", "K896095", "K944130", "K895209", "K961023", "K930997", "K871984", "K925097", "K981053", "K941224", "K953552", "K992698", "K973959", "K954691", "K955708", "K934386", "K950699", "K973421", "K980220", "K850417", "K882754", "K950513", "K973131", "K980684", "K973090", "K973303", "K911405", "K953514", "K992352", "K925864", "K960809", "K952533", "K943383", "K960911", "K953080", "K942917", 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"medical_specialty_description": "Radiology", "regulation_number": "892.2020", "device_class": "1" } } ] }