{ "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": "2026-10-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "208807", "product_res_number": "Z-2509-2024", "event_date_initiated": "2024-06-28", "event_date_posted": "2024-08-05", "recall_status": "Open, Classified", "res_event_number": "94919", "product_code": "MHX", "k_numbers": [ "K130849" ], "product_description": "IntelliVue Patient Monitor MX450 with L.x and M.x; K.x provided with L.x entitlements\nModel Number: 866062.\n\nIndicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.", "code_info": "UDI: 00884838038769", "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": "Philips Customer Services\n800-722-9377", "reason_for_recall": "Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software Options.\nChanges were made to reflect some options becoming standard capabilities for software-version N.x. In the process, the entitlements of software options MOS, M06, and M20 were removed for software versions L.x and M.x. As a result of these changes Patient Monitors manufactured with or updated to the latest versions of software L.x or M.x will not offer the capabilities> Mmonitors with software version K.x may experience this issue too, due to software version K being out of support and the devices being provided with L.x entitlements offered by software options MOS, M06, and M20. Potential for incorrect or delayed treatment for the patient,", "root_cause_description": "Software design", "action": "Philips North America issued URGENT Medical Device Correction on 6/25/24 to End-Users. Philips Market Organizations will distribute the letters outside of the U.S.\nLetter states reason for recall, health risk and action to take:\n\nUse only default measurement capabilities, as indicated in Table 1 above, for monitoring purposes.\nPass this notice to all those who need to be aware within your organization or to any organization where affected devices have been potentially transferred.\n\nA Philips representative will contact you to schedule a visit from a Philips Field Service Engineer who will reload the current device software to enable missing options (MOS, M06, M20).\nIf you need any further information, please contact your local Philips representative or call 1-800-722-9377.", "product_quantity": "49 units", "distribution_pattern": "Nationwide\nForeign:\nAustralia\nAustria\nBangladesh\nBrazil\nCanada\nChile\nChina\nColombia\nDenmark\nFrance\nGermany\nHong Kong\nIndia\nIndonesia\nItaly\nJapan\nNetherlands\nPortugal\nSingapore\nSouth Africa\nSouth Korea\nSpain\nSri Lanka\nSweden\nSwitzerland\nTaiwan\nThailand\nUnited Kingdom\nVietnam", "openfda": { "k_number": [ "K073203", "K113045", "K945134", "K033957", "K102562", "K090443", "K933624", "K001268", "K101692", "K132533", "K110622", "K130208", "K223531", "K122146", "K201764", "K923054", "K011918", "K003243", "K073462", "K080342", "K152407", "K121367", "K103134", "K231477", "K993608", "K251702", "K060223", "K053484", "K014261", "K962424", "K073280", "K153448", "K014213", "K033694", "K001664", "K051367", "K213799", "K191323", "K093268", "K133576", "K000815", "K123556", "K151027", "K170514", "K171901", "K080157", "K922974", "K002478", "K120598", "K181831", "K021325", "K030657", "K030038", "K221904", "K051400", "K945099", "K982091", "K180482", "K101449", "K950436", "K151080", "K142601", "K980619", "K003621", "K192514", "K191149", "K123048", "K190011", "K041235", "K151812", "K061993", "K134046", "K240320", "K040246", "K083271", "K052756", "K042904", "K973474", "K060221", "K102422", "K050762", "K001722", 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