{ "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": "210868", "product_res_number": "Z-0557-2025", "event_date_initiated": "2024-10-28", "event_date_posted": "2024-11-26", "recall_status": "Open, Classified", "res_event_number": "95642", "product_code": "LDD", "k_numbers": [ "K200849" ], "product_description": "Tempus LS-Manual Defibrillator Model 00-3020\n\nThe Tempus LS-Manual is a defibrillator that can deliver a shock in manual or Pacemaker mode", "code_info": "Model Number: 00-3020\nUDI-DI code: 07613365002737\nSerial Numbers:\n7022.000367\n7022.000387\n7022.000392\n7022.000462\n7022.000463\n7022.000464\n7022.000559\n7022.000591\n7022.000595\n7022.000711\n7022.000781\n7022.000786\n7022.00108\n7022.001175\n7022.001201\n7022.00129\n7022.001556\n7022.001582", "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 Services\n800-722-9377", "reason_for_recall": "Due to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and CAT number.", "root_cause_description": "Labeling Change Control", "action": "On 10/28/2024, Philips sent an \"URGENT Medical Device Correction\" Letter via Certified Mail to customers informing them that SCHILLER AG, the manufacturer of the Tempus LS Manual Defibrillator, informed Philips that the incorrect labels were supplied with the service kit (kits 3, 6 and 8). The affected labels can be identified by the wrong device name (TEMPUS LS instead of TEMPUS LS MANUAL), the wrong CAT number (00-3010 instead of 00-3020) and the additional CE marking. SCHILLER AG initiated a correction on 10/07/2024.\n\nCustomers are instructed to:\nShare this recall notice with those who need to be aware within their organization and any organization where the potentially affected devices have been transferred. It is recommended that the recall notice be posted on or near affected systems as a constant reminder of the issue until it is corrected.\n\nA Philips representative will contact affected customers to arrange for the corrected labels to be affixed to the affected Tempus LS Manual Defibrillators.\n\nFor questions or assistance, contact Philips at 1-800-722-9377 or email ECR.Recall.Repsonse@Philips.com", "distribution_pattern": "U.S. Nationwide distribution in the states of AL, CA, FL, MO, NY, OH, TX and VA.", "openfda": { "k_number": [ "K962551", "K801544", "K931787", "K780416", "K800936", "K852799", "K032691", "K912966", "K103159", "K842667", "K904462", "K140502", "K911402", "K910634", "K081442", "K923297", "K823931", "K831056", "K971355", "K930548", "K911455", "K921666", "K844103", "K823268", "K935111", "K813471", "K823933", "K842312", "K844447", "K882337", "K911456", "K903018", "K922173", "K914458", "K971194", "K910144", "K851092", "K874697", "K911662", "K951110", "K993205", "K905510", "K854175", "K853439", "K081574", "K871224", "K964469", "K922227", "K850618", "K103783", "K893990", "K982896", "K810237", "K922315", "K913484", "K150349", "K811638", "K921487", "K822294", "K882235", "K894355", "K895379", "K843229", "K971436", "K872793", "K921606", "K855082", "K012274", "K934508", "K842624", "K851485", "K103651", "K914971", "K911604", "K896903", "K935674", "K800937", "K863404", "K203231", "K921765", "K931803", "K851931", "K963781", "K854307", "K902478", "K923864", "K952085", "K941995", "K883617", "K902590", "K905065", "K920086", "K842235", "K895113", "K895032", "K910754", "K922563", "K042302", "K931053", "K812519", "K893403", "K885186", "K100654", "K200849", "K895651", "K871136", "K840258", "K102468", "K853354", "K895185", "K931805", "K903657", "K833751", "K890079", "K935083", "K931804", "K812520", "K880575", "K904466", "K894356", "K852808", "K832833", "K900169", "K922172", "K970481", "K912587", "K895533", "K822961", "K822617", "K103334", "K863303", "K902288", "K881153", "K812317", "K030417", "K931266", "K840246", "K934015", "K895009", "K182503", "K011461", "K840900", "K832827", "K823828", "K831696", "K891122", "K812586", "K781678", "K840167", "K851924", "K911665", "K874091", "K844740", "K874204", "K902782", "K863405", "K863899", "K940842", "K871135", "K843396", "K912621", "K864257", "K920990", "K902429", "K852905", "K895662" ], "registration_number": [ "3007029079", "1220908", "3010783192", "3003800159", "3010703925", "3017422354", "3015997711", "2183890", "3004035727", "3005521864", "1317188", "3012104670", "1417592", "3000126629", "3003615065", "3013500228", "8030978", "3004906872", "3003072803", "3011823740", "2246340", "1066270", "3005677568", "3013596024", "3008717264", "1930027", "3010317211", "3013826848", "3030677", "3000143502", "3009077524", "3007305485", "1320894", "3003832357", "3013557562", "1223925", "3014579161", "3015876" ], "fei_number": [ "3007029079", "1220908", "3010783192", "3003800159", "3010703925", "3017422354", "3015997711", "2183890", "3004035727", "3005521864", "1317188", "3012104670", "1417592", "3000126629", "3003615065", "3013500228", "3004906872", "3003072803", "3011823740", "2246340", "1000305720", "3005677568", "3013596024", "3008717264", "1930027", "3010317211", "3013826848", "3002808182", "3000143502", "3009077524", "3007305485", "3000957797", "3003832357", "3013557562", "3014579161", "1000524572", "3001451571", "3015876" ], "device_name": "Dc-Defibrillator, Low-Energy, (Including Paddles)", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.5300", "device_class": "2" } } ] }