{ "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": "190752", "product_res_number": "Z-0416-2022", "event_date_initiated": "2021-11-19", "event_date_created": "2021-12-22", "recall_status": "Terminated", "event_date_terminated": "2024-02-07", "res_event_number": "89203", "product_code": "OWB", "k_numbers": [ "K130842", "K141979", "K161563" ], "product_description": "Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures.\n\nModel Number: 722005, 722006, 722008, 722010, 722012, 722013, 722025, 722026, 722027, 722028.", "code_info": "US Serial Number/UDI:\n1\t (01)00884838054202(21)1;\n527\t(01)00884838059054(21)527;\n408\t(01)00884838054202(21)408;\n306\t(01)00884838054202(21)306;\n61\t (01)00884838059030(21)61\n\n\nOUS:\nModel Product S/N UDI:\n722006\tAllura Xper FD20\t1997\t(01)00884838059191(10)1997;\n722010\tAllura Xper FD10\t1177\t(01)00884838059030(21)1177;\n722010\tAllura Xper FD10\t1178\t(01)00884838059030(21)1178;\n722013\tAllura Xper FD20 Biplane\t544;;\t\n722010\tAllura Xper FD10\t514\t(01)00884838059030(21)514;\n722013\tAllura Xper FD20 Biplane\t271;\t\n722025\tAllura Xper FD20 Biplane OR Table\t6;\n722005\tAllura Xper FD10/10\t519;\t\n722008\tAllura Xper FD20 Biplane\t531;\t\n722012\tAllura Xper FD20\t1901\t(01)00884838059054(21)1901;\n722012\tAllura Xper FD20\t2505\t(01)00884838059054(21)2505;\n722013\tAllura Xper FD20 Biplane\t137;\t\n722026\tAllura Xper FD10\t439\t(01)00884838054189(21)439;\n722134\tField ext. Xper vascular systems R7.6\t98736;\t\n722027\tAllura Xper FD10/10\t172\t(01)00884838054196(21)172;", "firm_fei_number": "3016618143", "recalling_firm": "Philips North America Llc", "address_1": "222 Jacobs St", "city": "Cambridge", "state": "MA", "postal_code": "02141-2289", "reason_for_recall": "Set screws securing the two gliding rods of the Extra Monitors (called 7th and 8th monitor) mounted on the Monitor Ceiling Suspension (MCS) can come loose, the Extra monitors might disengage from the Mounting Ceiling Suspension structure and fall down, may lead to patient, user or service engineer harm that may require medical intervention.", "root_cause_description": "Other", "action": "Philips issued Medical Device Correction letter to US consignees on 19-Nov-2021. \tLetters outside of the U.S.A. will be distributed through the Philips Markets Organization.\nLetter states reason for recall, health risk and action to take:\nMove the MCS with a 7th or 8th monitor only before or after a procedure.\n\" Do not position the MCS above the patient/sterile field during the procedure.\n\" Place this Field Safety Notice with the system documentation until your system has been fixed.\n\" Circulate this notice to all users of this device so they are aware of the product issues.\n\" Return the attached reply form to Philips to confirm that the users of the system have reviewed and understood this Field Safety Notice.\nA Philips representative will secure the set of screws of all affected systems. You will be contacted by your local Philips representative to schedule the service.\n\nIf you need any further information, please contact your local Philips representative (reference to FC072200488).", "product_quantity": "USA: 5 systems \tR.O.W.: 15 systems", "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of DC, GA, MA, TX, VA and the countries of Dominican Republic, INDIA, Japan, Poland, Spain, Taiwan.", "openfda": { "k_number": [ "K133580", "K022069", "K982993", "K240099", "K222080", "K254173", "K093066", "K221922", "K252735", "K002016", "K123508", "K013608", "K142736", "K113027", "K181943", "K130638", "K060259", "K200917", "K070834", "K170752", "K120073", "K103425", "K936180", "K181670", "K030544", "K183144", "K201172", "K041605", "K251199", "K252068", "K190768", "K221281", "K212159", "K243328", "K200022", "K152696", "K212557", "K260607", "K251523", "K142126", "K211191", "K133292", "K961374", "K190064", "K152697", "K923049", "K221335", 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