{ "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": "2026-09-12", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "221888", "product_res_number": "Z-3141-2026", "event_date_initiated": "2026-07-31", "event_date_posted": "2026-09-11", "recall_status": "Open, Classified", "res_event_number": "99566", "product_code": "MHX", "k_numbers": [ "K153702" ], "product_description": "Philips Patient Information Center iX\r\nREF:866389", "code_info": "All PIC iX software versions 4.0-4.5/UDI: (01)00884838127067", "firm_fei_number": "3006648320", "recalling_firm": "Philips North America", "address_1": "222 Jacobs St", "city": "Cambridge", "state": "MA", "postal_code": "02141-2296", "additional_info_contact": "Philips Customer Services\n800-722-9377", "reason_for_recall": "Due to software malfunction, patient information system may freeze and become unresponsive.", "root_cause_description": "Software design", "action": "On July 31, 2026, Philips North America LLC issued an urgent medical device correction to affected consignees via USPS certified mail. Philips requested consignees to take the following actions: \nUsers:\n1. In cases where central monitoring has halted, please ensure that triaging of patients at bedside and a change in workflow occurs to more closely monitor patient status. Ensure audible alarm volume is on high in-patient rooms in case bedside devices disconnect and do not provide visual indicators that communication with the central.\n2. Pass this notice to those who need to be aware within your organization or to any organization where affected product(s) have been potentially transferred.\n3. Place this Urgent notification with the documentation of the Philips Patient Information Center (PIC) iX and associate devices in a place where it is most likely to be seen and viewed.\n4. Implement the Technical Solution established by Philips as soon as available within the defined timeframe.\n\nDistributors: \n1. Send the attached URGENT Medical Device Correction to each customer to whom you have distributed any affected product(s) \n2. Perform a good faith effort to reach each customer a minimum of three (3) times, and if\npossible, using multiple contact methods.\n3. Implement the Technical Solution established by Philips as soon as available within the\ntimeframe communicated by Philips, and confirm with Philips the implementation of the\ncorrection of all affected product(s). In case any product(s) cannot be corrected, inform Philips of the reason why the Technical Solution could not be implemented.", "product_quantity": "7359 Units", "distribution_pattern": "Worldwide - US Nationwide distribution including in the states and territories of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR and the countries of Andorra, Utd. Arab. Emir., Argentina, Austria, Australia, Aruba, Bosnia-Herz., Bangladesh, Belgium, Bulgaria, Bahrain, Bolivia, Brazil, Canada, Switzerland, Chile, Colombia, Costa Rica, Cyprus, Czech Republic, Germany, Denmark, Dominican Rep, Algeria, Estonia, Spain, Finland, Fiji, Faroe Islands, France, United Kingdom, Gibraltar, Guadeloupe, Greece, Hong Kong, Croatia, Hungary, Indonesia, Ireland, Israel, India, Iraq, Iceland, Italy, Jordan, Japan, Kenya, South Korea, Kuwait, Lebanon\t, Sri Lanka, Lithuania, Luxembourg, Latvia, Libya, Morocco, Monaco, Montenegro, Macedonia, Macao, Martinique, Maldives, Mexico, Malaysia, Namibia, Nicaragua, Netherlands, Norway, New Zealand, Oman, Panama, Peru, Philippines, Pakistan, Poland, Puerto Rico, Portugal, Qatar R¿union, Romania, Serbia, Russian Fed., Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Thailand, Turkmenistan, Tunisia, T¿rkiye, Taiwan, Ukraine, Uzbekistan, Vietnam, South Africa.", "openfda": { "k_number": [ "K942700", "K131872", "K063315", 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"3004196561", "3007413079", "1000122786" ], "device_name": "Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1025", "device_class": "2" } } ] }