{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "183802", "product_res_number": "Z-0071-2021", "event_date_initiated": "2020-09-11", "event_date_created": "2020-10-08", "recall_status": "Terminated", "event_date_terminated": "2024-09-24", "res_event_number": "86474", "product_code": "LMD", "product_description": "VGDF-SKY (R4-010-06) VGA TO FIBER CONVERTER-Single Format Faceplate, a component of the SkyVision Linx 300 Integration Control System\nModel: VGDF-SKY (version 2). For communication and visual image management in the operating room suite.", "code_info": "Serial Numbers: MXDM200501769 MXDM200501773 MXDM191100421 MXDM191100422 MXDM200200161 MXDM200200162 MXDM200200163 MXDM200200164 MXDM200501770 MXDM200501772 MXDM200501771", "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": "VGDF (VGA) Faceplate failure results in failure of video signal for SkyVision Linx 300, a secondary display. Video would continue on the primary source device display", "root_cause_description": "Software design", "action": "Skytron notified authorized representatives on September 11, 2020 via email states reason for recall and action to take: Please let us know if you have deployed these into a facility. We will provide new replacement VGA faceplates. Skytron is scheduled to receive the replacements from Opticis by Oct 12.\nProcess:\n1.)Please enter a no charge PO and you will receive an RMA for the faceplates. (returns@skytron.us)\n2.)Skytron will send new faceplates.\n3.)Complete & return the attached acknowledgement form. (This is an FDA recall and paperwork is essential!)\n4.)Return original VGA faceplate to Skytron.\n\nThe Customer Acknowledgement form states reason and health risk and will be completed for each facility signed by the Distributor Representative and Customer", "product_quantity": "11 units", "distribution_pattern": "AZ, MI, MS, NJ, PA,", "openfda": { "k_number": [ "K950431", "K926098", "K960382", "K972701", "K930500", "K850417", "K963594", "K940423", "K953080", "K973421", "K991537", "K914444", "K931186", "K973090", "K931060", "K980241", "K970652", "K980220", "K974107", "K973303", "K954691", "K925097", "K933103", "K992426", "K942917", "K955000", "K950699", "K862715", "K953163", "K905199", "K973793", "K921185", "K943158", "K896095", "K960809", "K963861", "K953371", "K974882", "K994329", "K940408", "K980684", "K950413", "K973959", "K961023", "K970293", "K936153", "K952533", "K944130", "K941224", "K963592", "K924229", "K926315", "K920268", "K871984", "K961753", "K954071", "K980541", 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"3013757696" ], "device_name": "System, Digital Image Communications, Radiological", "medical_specialty_description": "Radiology", "regulation_number": "892.2020", "device_class": "1" } } ] }