{ "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": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "195576", "product_res_number": "Z-1563-2022", "event_date_initiated": "2022-02-25", "event_date_posted": "2022-09-01", "recall_status": "Open, Classified", "res_event_number": "90728", "product_code": "KPR", "k_numbers": [ "K163410", "K201725" ], "product_description": "DigitalDiagnost C50 1.1", "code_info": "Model Number 712204   Serial Number 210182 210187 220002 210049 210051 210097 210052 210053 210055 220020", "firm_fei_number": "3016618143", "recalling_firm": "Philips North America Llc", "address_1": "222 Jacobs St", "city": "Cambridge", "state": "MA", "postal_code": "02141-2289", "additional_info_contact": "Dusty Leppert, CHP \n978-228-0190", "reason_for_recall": "Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect orientation of the image on the first examination due to an issue in the firmware of the Wallstand VS2 board. The system will rotate the amplimat field selection by 90 degrees. The wrong amplimat field selection may cause an incorrect dose of radiation to occur. Additionally, the anatomic position markers may become mispositioned and could potentially be associated with the opposite side of the anatomy. \n(Added 1/3/2023), Expansion of the root cause to include incorrect amplimat field selection by 90 degrees following the first exposure using Wallstand VS2 and a subsequent system restart. Previously, this issue only occurred following a system restart where the Table Height 2 (TH2) is the default setting.", "root_cause_description": "Software Design Change", "action": "Philips notified customers of the issue via an Electronic Product Radiation Defect notification letter dated July 12, 2022. Philips will schedule an appointment with customers to install the software update at no cost to customers. For questions contact Philips Customer Care Solutions Center 1-800-722-9377.", "product_quantity": "11 systems (updated 1/3/2023)", "distribution_pattern": "Nationwide Distribution including Puerto Rico", "openfda": { "k_number": [ "K182134", "K231892", "K810973", "K250954", "K133959", "K140334", "K913659", "K934755", "K080614", "K190601", "K070678", "K080582", "K841756", "K973219", "K810797", "K233662", "K192453", "K202572", "K091889", "K213700", "K900562", "K122726", "K230800", "K972000", "K945278", "K202293", "K173828", "K982824", "K233722", "K781613", "K920558", "K920347", "K193089", "K101435", "K193225", "K023008", "K921539", "K063246", "K934005", "K203537", "K193574", "K133259", "K870300", "K242678", "K152767", "K872525", "K915362", "K182622", "K172869", "K193637", "K173517", "K260482", "K214012", "K011486", "K950980", "K221853", "K043025", "K220919", "K981056", "K013481", "K152294", "K173823", "K242478", "K833559", "K944613", "K060550", "K883834", "K872316", "K233719", 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