{ "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": "141182", "product_res_number": "Z-0273-2016", "event_date_initiated": "2014-11-19", "event_date_posted": "2015-11-13", "recall_status": "Terminated", "event_date_terminated": "2017-09-12", "res_event_number": "72477", "product_code": "MKJ", "k_numbers": [ "K031187", "K040404", "K051134", "K061707" ], "product_description": "ECG Out Cable,for use with a Philips ALS monitor/ defibrillator and bedside monitor for Synchronized cardioversion and Transcutaneous pacing. M1783A/M5526A 12-pin Sync cables, used with HeartStart MRx and HeartStart XL and HeartStart XL+", "code_info": "All Philips M1783A and M5526A sync cables are affected by this issue. The model number is printed on the outside of the cable, near the end with the ¿ inch phone plug.", "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": "800-722-9377", "reason_for_recall": "When a Philips monitor/defibrillator is receiving an ECG signal from an auxiliary bedside monitor via a sync cable, the following can occur if the monitor/defibrillator experiences interference from electrical fast transients (EFTs) while connected to AC power: On the HeartStart MRx and HeartStart XL, EFT noise can be misinterpreted as an R-wave. On the HeartStart XL+, EFT noise can disable ECG monitoring, and potentially interrupt demand mode pacing.", "root_cause_description": "Device Design", "action": "Philips sent an Urgent - Field Safety Notice dated November, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. \n\nPhilips plans to take to remedy the issue. A replacement cable will be provided free of charge for all units affected by this issue. A Philips Healthcare representative will contact customers with affected devices to arrange for installation of the upgrade. Philips is asking customers to follow the: Action to be Taken by Customer/User section of the Urgent Medical Device Correction notification/Field Safety Notice: Prior to receiving a replacement sync cable, you can continue to use affected sync cables, provided that they are only used to connect the ECG Out jack on the monitor/defibrillator to the ECG (input) port on a bedside monitor. The issues described in this letter do not impact this application of the sync cable.\nAffected sync cables should not be used to connect the ECG Out jack of a bedside monitor to the ECG (input) port on the monitor/defibrillator.\n\nFor further questions please call (800) 722-9377.", "product_quantity": "18,604", "distribution_pattern": "Worldwide Distribution - US (nationwide) and to the countries of : Argentina, Australia, Austria, Bahrain, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Ethiopia, Finland, France, Gabon, Germany, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kenya, Republic of Korea, Latvia, Lebanon, Macau, Malaysia, Mexico, Netherlands, New Zealand, Nigeria, Norway, Oman, Philippines, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela and Yemen.", "openfda": { "k_number": [ "K032439", "K971148", "K896919", "K992543", "K860676", "K983393", "K003565", "K040256", "K091561", "K031187", "K853564", "K030898", "K011144", "K103567", "K953204", "K955628", "K120406", "K111594", "K012766", "K002232", "K133484", "K150055", "K120536", "K993036", "K122600", "K020984", "K033771", "K993072", "K120907", "K060934", "K072430", "K110825", "K063510", "K041067", "K111693", "K130684", "K010214", "K063119", "K091265", "K123881", "K962359", "K932931", "K062177", "K942850", "K092598", "K943698", "K002445", "K142430", "K143714", "K955923", "K080421", "K040438", "K120350", "K935922", "K061707", "K012428", "K980857", "K003548", "K141774", "K040404", "K990762", "K112432", "K991556", "K954957", "K122839", "K100565", "K011901", "K052057", "K113787", "K040637", "K002806", "K081081", "K964991", "K041883", "K090989", "K072812", "K022732", "K934692", "K062537", "K062970", "K032051", "K133441", "K882067", "K082937", "K955828", 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