{ "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": "187783", "product_res_number": "Z-1997-2021", "event_date_initiated": "2021-05-25", "event_date_created": "2021-07-01", "recall_status": "Open, Classified", "res_event_number": "88051", "product_code": "MHX", "k_numbers": [ "K201746" ], "product_description": "Tempus Pro - Patient physiological monitor, arrhythmia detector and alarm.\nPart No. - 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. Product Usage: intended to be used as a stand-alone monitor or as a telemedicine system (transmitting patient data to other medical professionals located elsewhere).", "code_info": "Software version number: v07.00, v07.01, v07.18, v07.20, v07.22, v07.24.   UDI No. 12NC No. 05060472440020\t989706002081 05060472440013\t989706000001 05060472441027\t989706000051 05060472441058 989706000101", "firm_fei_number": "3003832357", "recalling_firm": "Remote Diagnostic Technologies Ltd.", "address_1": "PAVILION C2, ASHWOOD PARK c2 pavilion ashwood park ashwood way", "city": "Basingstoke", "country": "United Kingdom", "additional_info_contact": "Philips Customer Services\n800-722-9377", "reason_for_recall": "The Tempus Pro (Trizeps 7 only) when used in combination with a specified laryngoscope device can cause two error types when subsequently unplugged.", "root_cause_description": "Software design", "action": "On June 2, 2021, Philips issued an Urgent Medical Device Correction notice to customers via letter and email notifying them an intermittent software error has been detected as a part of an internal production control activity. The error can occur immediately after unplugging the Video Laryngoscope from the USB port.\n\nIf the customer identifies affected products in use or in inventory: Clinical User Actions:\n-\tUsers of Tempus Pro who are not using a Video Laryngoscope do not need to take any further actions.\n-\tWhen a Video Laryngoscope is required to be used, the following actions are recommended to reduce the probability of a software reboot during the intervention;\n-\tAn alternative Video Laryngoscope device may be used to perform any critical interventions such as intubation.\n-\tIf you are using the Tempus Pro and need to use the Video Laryngoscope on a patient, we recommend completion of any critical interventions before unplugging the Video Laryngoscope from the USB port.\n-\tShould the Video Laryngoscope image become frozen on the screen, re-start (turn off and turn back on) the Tempus Pro device.\n\nCustomer Actions:\n-\tNotify all users of the potential risk of loss of monitoring when unplugging the Video Laryngoscope from the Tempus Pro, requiring the device to be restarted.\n-\tThis issue is limited to specific serial numbers. Please verify that your device is associated with the product included in the scope of this notice utilising attachment 1.\n-\tReturn your completed Customer Reply form to the email address below, to allow RDT to provide the software update:\n-\tEmail completed and signed form to: RDT.Recall.Response@Philips.com", "product_quantity": "510 systems", "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of FL, TX, PA, MN, UT, MT, CA, WI, VA, NY, TN, KS, MD and the countries of Australia, Austria, Czech Republic, France, Germany, Hong Kong, Israel, Italy, Netherlands, Thailand, Abu Dhabi, UK.", "openfda": { "k_number": [ "K051367", "K121480", "K080342", "K033365", "K123472", "K101692", "K022485", "K033048", "K092027", "K052801", "K040304", "K062098", "K033600", "K041607", "K911051", "K011000", "K221348", "K142601", "K061052", "K950264", "K102495", "K150329", "K223531", "K993974", "K001433", "K103646", "K123048", "K102239", "K213181", "K103134", 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