{ "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": "2026-09-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "198918", "product_res_number": "Z-1321-2023", "event_date_initiated": "2023-02-23", "event_date_posted": "2023-04-01", "recall_status": "Open, Classified", "res_event_number": "91805", "product_code": "MHX", "k_numbers": [ "K201746" ], "product_description": "Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel, for the attended or unattended monitoring of single or multiple vital signs in clinical and pre hospital care applications.\n\nThe affected power supplies are related to the following Tempus Pro Patient Monitoring units:\n\nModel Numbers:\n00-1004\n00-1004-R\n00-1007\n00-1007-R\n00-1024-R\n00-1026-R\nModel Numbers:\n00-1004\n00-1004-R\n00-1007\n00-1007-R\n00-1024-R\n00-1026-R", "code_info": "Model Numbers:\n00-1004\n00-1004-R\nUDI-DI Codes:\n05060472440020\n05060472442901\n\n00-1007\n00-1007-R\nUDI-DI Codes:\n05060472440013\n05060472442901\n\n00-1024-R\nUDI-DI Codes:\n05060472441027\n05060472442925\n\n00-1026-R\nUDI-DI Codes:\n05060472441058\n05060472442932\n\nLot Codes - All products manufactured are affected.", "firm_fei_number": "3003832357", "recalling_firm": "Remote Diagnostic Technologies Ltd.", "address_1": "Farnborough Aerospace Centre Aerospace Boulevard", "city": "Farnborough", "country": "United Kingdom", "additional_info_contact": "Philips Customer Service\n800-722-9377", "reason_for_recall": "During internal testing, Regulatory Compliance issues were identified regarding the Monitor and Power Supplies for fluid ingress and basic safety issues.", "root_cause_description": "Under Investigation by firm", "action": "On 02/17/2023, the firm sent an \"URGENT Medical Device Correction\" Letter via priority mail to customers informing them that during internal testing, Regulatory Compliance issues regarding Fluid Ingress and Basic Safety issues were identified with the Tempus Pro Monitor, AC Mains Power Supply, and the Vehicle Adaptor.\n\nCustomers are instructed to:\n\"\tAs there is currently no indication that any of the issues have resulted in a degradation in product performance, Philips advises that the Tempus Pro devices should remain in service. \n\"\tContinue to follow the User/Operator Manual, including:\no\tTake care to ensure that water or liquids are not spilt over the device or into its ventilation holes in the side corners. \no\tCheck connector covers, particularly the capnometer door cover, to ensure they close and latch acceptably. \n\"\tPost this Urgent Medical Device Correction letter on or near your Tempus Pro device. \n\"\tComplete and return the Urgent Medical Device Correction response form included, no later than 30 days from receipt. \n\nPhilips will be providing a new and compliant AC Mains Power Supply to all affected customers. A new and compliant Vehicle Adaptor will also be provided to affected customers with devices that include that option. Philips anticipates providing this solution to customers in the second half of 2023.\n\nFor questions or further information, contact the local Philips Representative, or Philip at (800)263-3342.", "product_quantity": "5,540 units", "distribution_pattern": "Worldwide Distribution: U.S.(nationwide): AL, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI, WV, WY and O.U.S.(foreign): United Arab Emirates, Afghanistan, Austria, Australia, Belgium, Brunei Darussalam, Bolivia, Canada, Switzerland, Czechia, Germany, Denmark, Spain, France, United Kingdom, Hong Kong, Ireland, Israel, Iceland, Italy, Cayman Islands, Luxembourg, Malaysia, Netherlands, Norway, Portugal, Romania, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, Mayotte, and South Africa.", "openfda": { "k_number": [ "K213181", "K002209", "K131829", "K950264", "K213799", "K173036", "K200494", "K122146", "K031781", "K192137", 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"K062095", "K000854", "K131876", "K142601", "K060223", "K093501", "K021325", "K030613", "K101067", "K031403", "K912627", "K001268", "K081793", "K030722", "K033694", "K092027", "K102495", "K223574", "K170155", "K053121", "K050742", "K041741", "K970182", "K881643", "K970445", "K080251", "K211900", "K171801", "K942700", "K920445", "K090556", "K983996", "K150352", "K131971", "K131872", "K912835", "K041087", "K223531", "K130208", "K103646", "K022889", "K080342", "K990563", "K221879", "K252589", "K112803", "K031320", "K051628", "K070566", "K980411", "K043439", "K102562", "K073203", "K030431", "K152552", "K911051" ], "registration_number": [ "3032109181", "3012528160", "3009831876", "3009443693", "3000126629", "3006087789", "3030446844", "9610816", "3007836437", "3013501110", "3014263632", "1000122786", "3009490946", "1066270", "3021559257", "3003591740", "3013679558", "3004196561", "8030978", "1218950", "8022257", "3018783526", "3016674095", "3007413079", "3012238587", "3005521864", 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"3014848734", "3007048291", "3011353843", "3014633893", "3016701404", "3011120183", "3020115", "3017446092", "8030229", "3008058135", "3010703925", "2080783", "3010882708", "1054713", "3015997711", "3015181391", "3008483389", "3009973336", "3003971136", "2221819" ], "fei_number": [ "3032109181", "3002807720", "3012528160", "3009831876", "3009443693", "3000126629", "3000215024", "3006087789", "3003513129", "3000957797", "3030446844", "3007836437", "3013501110", "3014263632", "1000122786", "3009490946", "3021559257", "3003591740", "3013679558", "3004196561", "1218950", "3018783526", "3016674095", "3007413079", "3012238587", "3005521864", "3008255748", "3007305624", "3008642652", "3009673645", "3009715978", "3002806783", "3013896610", "2025816", "3004415095", "3016852448", "1930027", "3003589956", "1000300598", "3007481893", "3005877899", "3006979678", "3008716327", "3003757840", "1316463", "3009077524", "3013596024", "3009607734", "3009156722", "3013557562", "3016618143", "3000162901", 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Arrhythmia Detection Or Alarms)", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1025", "device_class": "2" } } ] }