{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 3 } }, "results": [ { "cfres_id": "171735", "product_res_number": "Z-1199-2019", "event_date_initiated": "2019-03-15", "event_date_created": "2019-04-18", "recall_status": "Open, Classified", "res_event_number": "82514", "product_code": "IZI", "k_numbers": [ "K111209" ], "product_description": "Innova IGS 630, Angiographic X-Ray, s5i system option used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.", "code_info": "Model Number 5503558; System ID Number 0850060757; Serial Number B3-16-015", "firm_fei_number": "2126677", "recalling_firm": "GE Healthcare, LLC", "address_1": "3000 N Grandview Blvd", "city": "Waukesha", "state": "WI", "postal_code": "53188-1615", "additional_info_contact": "800-437-1171", "reason_for_recall": "There is a potential for loss of the x-ray imaging function when the user changes field of view (FOV) from 30cm to 20cm or from 20cm to 30cm while releasing the fluoroscopy footswitch pedal simultaneously.", "root_cause_description": "Device Design", "action": "GE Healthcare notified customers on about 03/15/2019 via \"URGENT MEDICAL DEVICE CORRECTION\" letter. Customer were informed that they can continue to use their Innova IGS 6 or Innova IGS 630 Systems but must follow the following safety instructions: 1. Do not change the size of the field of view from 30cm to 20cm or 20cm to 30cm while releasing the fluoroscopy footswitch pedal. 2. Only perform these 2 actions sequentially. 3. If the system becomes locked up, perform a reset to recover functionalities. \n\nCustomers were also informed that GE Healthcare will correct all affected products at no cost and a GE Healthcare representative will contact each customer to perform the correction. After the GE representative has updated the system, please destroy previous Innova IGS 6 SW package installation media related to this system (versions prior to IGS6_2.2.1 or IGS6_3.1.1). \n\nQuestions or concerns can be directed to GE Healthcare Service at 1-800-437-1171 or your local Service Representative.", "product_quantity": "1 device", "distribution_pattern": "Nationwide distribution to AR, CA, CA, FL, MI, NM, NV, SC, TN, TX, VA, WA, WI. \n\nInternational distribution to Algeria, Belgium, China, Colombia, France, Hungary, Italy, Japan, Korea (Republic Of), Kuwait, Libya, Pakistan, Poland, Russia, Saudi Arabia, South Africa, Sudan, Turkey, Vietnam.", "openfda": { "k_number": [ "K961451", "K903371", "K941946", "K942120", "K915199", "K905653", "K875373", "K850455", "K113594", "K243645", "K905518", "K913120", "K982203", "K882358", "K960575", "K023970", "K904540", "K130842", "K941177", "K071717", "K926258", "K032443", "K955179", "K253181", "K903941", "K924708", "K924137", "K883072", 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"System, X-Ray, Angiographic", "medical_specialty_description": "Radiology", "regulation_number": "892.1600", "device_class": "2" } } ] }