{ "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": "142026", "product_res_number": "Z-0858-2016", "event_date_initiated": "2015-11-25", "event_date_posted": "2016-02-23", "recall_status": "Terminated", "event_date_terminated": "2017-09-06", "res_event_number": "72720", "product_code": "MHX", "k_numbers": [ "K102495" ], "product_description": "Philips Healthcare IntelliVue Info Center iX, B.0, 866389\n Physiological, Patient Monitor (With Arrhythmia Detection or Alarm)", "code_info": "Software Versions: B.0.X", "firm_fei_number": "1218950", "recalling_firm": "Philips Electronics North America Corporation", "address_1": "3000 Minuteman Rd", "city": "Andover", "state": "MA", "postal_code": "01810-1032", "additional_info_contact": "Kelly Rector\n978-659-2950", "reason_for_recall": "Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in specific leads.", "root_cause_description": "Software Design Change", "action": "Philips Healthcare issued a Field Safety Notice on 11/25/15 to inform customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue.Philips will provide a software correction free of charge. On 1/28/16 the Philips issued an updated letter to users.Philips has initiated a correction to address this issue. A software correction will be provided to customers with impacted devices at no charge.\n\nPhilips is asking customers to follow the Action to be Taken by Customer/User section of the Field Safety Notice: \nArrhythmia alarms are not affected. ST alarms, ST values and measurements are also not affected and could be used to assist with the decision to obtain a diagnostic ECG.\n\nThe ECG waves at the bedside are not affected. Printing ECG waves from the bedside is an alternative to printing from the PIIC iX.\n\nIf you need any further information or support concerning this issue, contact your local Philips Healthcare Customer Service representative or the Customer Care Solutions Center at (800) 722-9377 with questions or concerns about this Device Correction.", "product_quantity": "1880 units", "distribution_pattern": "Worldwide Distribution-US (nationwide) and the countries of Algeria Australia Austria Belgium Bulgaria Canada Denmark Estonia Finland France Germany Hong Kong Hungary Iceland India Indonesia Iraq Ireland Israel Italy Japan Kenya Korea Kuwait Luxembourg Malaysia Mongolia Morocco Netherlands New Zealand Nigeria Norway Poland Qatar Romania Russian Federation Saudi Arabia Singapore Slovenia South Africa Spain Sweden Switzerland Taiwan Turkey United Arab Emirates and United Kingdom.", "openfda": { "k_number": [ "K191106", "K112190", "K242962", "K122439", "K053121", "K061993", "K051217", "K050742", 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Detection Or Alarms)", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1025", "device_class": "2" } } ] }