{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "168731", "product_res_number": "Z-0603-2019", "event_date_initiated": "2018-11-23", "event_date_created": "2018-12-13", "recall_status": "Terminated", "event_date_terminated": "2020-09-29", "res_event_number": "81443", "product_code": "MKJ", "k_numbers": [ "K051134" ], "product_description": "HeartStart MRx, Rechargeable Li-Ion (lithium ion battery), REF: M3538A, which is a component of HeartStart MRx Monitor/Defibrillators.", "code_info": "UDI: (01)00884838002791; Serial Numbers: 17362-0001-P through 18057-0266-P", "firm_fei_number": "1000524572", "recalling_firm": "Philips North America LLC", "address_1": "22100 Bothell Everett Hwy", "city": "Bothell", "state": "WA", "postal_code": "98021-8431", "additional_info_contact": "1800-722-9377", "reason_for_recall": "Affected lithium-ion batteries may contain a defective component (Thermal Cut-off or TCO). Should the component fail, the battery will no longer charge or deliver power to the Monitor/Defibrillator, which may prevent operation of the device if it is not connected to AC or DC power. Should a second, unaffected battery be present in the Monitor/Defibrillator, the battery failure may go unnoticed.", "root_cause_description": "Nonconforming Material/Component", "action": "On 11/23/2018 Urgent Medical Device Recall notices were mailed via USPS certified mail to customers. Customers were instructed to do the following. Inspect the batteries installed in your monitor/defibrillator to determine if they are affected by this recall. If any affected batteries are found, remove them from service immediately, along with any other affected batteries in your inventory. Further, customers were asked to complete and fax the Customer Reply Form to: +1.877.499.7223 or email to recall.response@philips.com.\n\nYour monitor/defibrillator can only be returned to service once a charged battery, unaffected by this recall, is installed.\n\nFirm will replace affected Rechargeable Lithium-Ion Batteries at no charge to the customer. Firm will contact you when replacement batteries are available.\n\nCustomers with additional questions are encouraged to call 1-800-722-9377.\n\nDistributors were advised to send a copy of the Urgent Medical Device Recall notice and Customer Reply form to any customer to whom they have distributed affected batteries.", "product_quantity": "1880 Batteries", "distribution_pattern": "U.S.: AZ, WA, PA, UT, NY, CO, MD, AR, TX, MO, MI, FL, VA, MA, GA, TN, NV, OH, CA, NH, KY, KS, OR, WI, NC, IL, LA, NJ, WV, AL, WY, MS\n\nForeign (OUS): United Kingdom, Korea Rep, Singapore, Australia, Taiwan, Sri Lanka, Brazil, France, Switzerland, Germany, Austria, Spain, Italy, Trinidad and Tobago, Estonia, Belgium, Portugal, Korea, Republic of, Argentina, India, Puerto Rico, Qatar, Netherlands, Mexico, South Africa, Ireland, Saudi Arabia, New Zealand, Bolivia, Costa Rica, Chile, Canada, Russian Federation, Slovenia", "openfda": { "k_number": [ "K982710", "K042404", "K051632", "K883584", "K962359", 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