{ "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": "183863", "product_res_number": "Z-0298-2021", "event_date_initiated": "2020-09-21", "event_date_created": "2020-10-27", "recall_status": "Terminated", "event_date_terminated": "2021-08-03", "res_event_number": "86512", "product_code": "OWB", "k_numbers": [ "K133580" ], "product_description": "Siemens Artis one systems with a Display Port transceiver-Fluoroscopic X-Ray System Model: 10848600 - Product Usage: he examination table as an integrated part of the system can be used for X-ray imaging, surgery and interventions. The Artis one can also support the acquisition of position triggered imaging for spatial data synthesis.", "code_info": "Serial Numbers: 82010 82038 82039 82040 82044 82054 82065 82066 82070 82102 82105 82108 82109 82205 82213 82217 82267 82308 82354 82355 82378 82383", "firm_fei_number": "2240869", "recalling_firm": "Siemens Medical Solutions USA, Inc", "address_1": "40 Liberty Blvd", "city": "Malvern", "state": "PA", "postal_code": "19355", "additional_info_contact": "SAME\n610-219-4834", "reason_for_recall": "Potential malfunction in which the examination room monitor may become intermittently dysfunctional (e.g., no display/flicking/wrong resolution).", "root_cause_description": "Component design/selection", "action": "Siemens issued Urgent Medical Device Correction notification letter dated 9/22/20 via AX053/20/S stating reason for recall, health risk and action to take: \nSiemens will correct the error with a hardware replacement of the Display Port transceiver via Update Instruction AX052/20/S. Our service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. Following the correction, the cause is eliminated, and any recurrence of this potential fault is prevented. Please review, understand, and confirm acknowledgement of the information and instructions outlined in this\nUrgent Safety Advisory Notice. By signing this document.", "product_quantity": "22 units", "distribution_pattern": "US Nationwide distribution including in the states of AL, AR, AZ, CA, FL, IN, LA, MI, MO, NC, NJ, NY, PA, TX, WA.", "openfda": { "k_number": [ "K231700", "K130638", "K181830", "K133278", "K232298", "K010435", "K200074", "K151598", "K101833", "K220432", "K023178", "K010942", "K112180", "K923049", "K251602", "K243328", "K240199", "K162148", "K220409", "K081073", "K082243", "K171755", "K221922", "K172700", "K193326", "K211782", "K162614", "K123508", "K160088", "K234109", "K252099", "K212159", "K213768", "K132558", "K183109", "K251520", "K171565", "K223410", "K233230", "K200022", "K172307", "K222080", "K253670", "K173314", "K211777", "K140138", "K963952", "K243884", "K182546", "K160147", "K242731", "K181415", "K161756", "K092004", "K042053", "K970063", "K181670", "K171829", "K230871", "K250010", "K250241", "K002198", "K921219", "K092438", "K210054", "K230787", "K080847", "K254205", "K122644", "K100102", 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