{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "216239", "product_res_number": "Z-0296-2026", "event_date_initiated": "2025-09-12", "event_date_posted": "2025-10-23", "recall_status": "Open, Classified", "res_event_number": "97647", "product_code": "KPS", "product_description": "Maxicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging", "code_info": "all serial numbers in distribution", "firm_fei_number": "3027338963", "recalling_firm": "GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING", "address_1": "9, Andrey Sakharov 9 Andrey Sakharov", "city": "Haifa", "country": "Israel", "additional_info_contact": "GE HealthCare Service\n800-437-1711", "reason_for_recall": "GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.", "root_cause_description": "Package design/selection", "action": "GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 9/12/2025 via letter (USPS first class). The notice explained the issue, potential safety issue, and requested the following: \n\"Actions to be taken by Customer/User: \nYou have previously been formally notified that these Impacted Systems have reached their End of Guaranteed Service life. GE HealthCare does not have the ability to correct these devices. GE HealthCare requests you to immediately STOP USING your Impacted System(s). As these devices are no longer supported and are no longer serviceable, continued use may compromise patient or user safety, negatively impact product performance, or introduce other risks to patients, users, and facilities. \nThis is the final communication from GE HealthCare regarding these devices.\nPlease ensure all potential users in your facility are made aware of this Stop Use safety notification.\nTake care when deinstalling the system, ensuring the system is balanced and all parts are secure. If you require assistance in removal and disposal of your system, please contact your local GE HealthCare representative.\nIf you would like to discuss your replacement options, please contact your GE HealthCare account representative.\nPlease retain this document for your records. \nContact Information: If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.\" \nOn 10/01/2025, the firm sent a follow-up notice removing Millenium VG from this action as it was erroneously included in the first notice.", "product_quantity": "37 units", "distribution_pattern": "Worldwide", "openfda": { "k_number": [ "K981553", "K033254", "K926206", "K082506", "K093514", "K980715", "K042880", "K033782", "K123599", "K243186", "K011572", "K013353", "K923736", "K973396", "K991129", "K070589", "K041543", "K925186", "K936001", "K050366", "K162736", "K914296", "K161674", "K926133", "K261315", "K972509", 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