{ "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": 1 } }, "results": [ { "cfres_id": "213123", "product_res_number": "Z-1556-2025", "event_date_initiated": "2025-03-06", "event_date_posted": "2025-04-11", "recall_status": "Open, Classified", "res_event_number": "96538", "product_code": "IYN", "k_numbers": [ "K203137", "K220848", "K234106" ], "product_description": "Venue Fit Models: R3 (Model Number H45303VFSC, H45303VFSW), R4 (Model Number H45314VFS, H45314VFSW), Venue Fit R5 system (Model Numbers H45335VFS, H45335VFSW), R3 Surgery for China, R3 PeriOP for China, R3 Expert for China, R3 Pro for China, R3 Performance for China, R3 Intervention for China diagnostic ultrasound systems", "code_info": "UDI-DI: Venue Fit R3 system (GTIN 00195278194275 / GTIN 00195278361400);\nVenue Fit R4 system (GTIN 00195278516497 / GTIN 00195278516503);\nVenue Fit R3 Surgery for China (GTIN 00195278552488);\nVenue Fit R3 PeriOP for China (GTIN 00195278552501);\nVenue Fit R3 Expert for China (GTIN 00195278552402);\nVenue Fit R3 Pro for China (GTIN 00195278552419);\nVenue Fit R3 Performance for China (GTIN 00195278552440);\nVenue Fit R3 Intervention for China (GTIN 00195278552495);\nVenue Fit R5 system (GTIN 00195278424938 / GTIN 00195278425041);\n\nSerial IDs: 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"firm_fei_number": "2126677", "recalling_firm": "GE Medical Systems, LLC", "address_1": "3000 N Grandview Blvd", "city": "Waukesha", "state": "WI", "postal_code": "53188-1615", "reason_for_recall": "The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire.", "root_cause_description": "Under Investigation by firm", "action": "An URGENT MEDICAL DEVICE CORRECTION notification letter dated 3/6/25 was sent to customers. \n\nActions to be taken by Customer/User:\nYou can continue to use your Venue Go and Venue Fit system after following the actions below:\n1) Turn the system Off and unplug the system from the wall socket.\n2) Remove the system batteries by following instructions provided in the User Manual Chapter 3. These instructions are also provided in this letter in Appendix A for Venue Go and in Appendix B for Venue Fit.\n3) Check the date of manufacture of the system batteries by looking at the label on the bottom of each battery (See Figure 1). The date of manufacture is displayed as YYYY-MM for year and month of manufacture.\nNOTE: Venue Go has two batteries and Venue Fit has one battery\n4) Calculate the age of each of the system batteries.\n5) If any of the batteries are more than 2 years old:\na. With the system unplugged, re-insert batteries, turn the system On and leave the system On to discharge the batteries.\nb. Once the battery capacity indicator shows two segments or less (See Figure 2), turn the system Off and remove the batteries per step 2.\nc. Dispose of batteries according to local regulations.\nNOTE: After battery removal, you can continue to use the system with use of AC power cord. The system is fully functional without the battery.\n6) If the batteries are less than 2 years old, you may continue to use the battery until the battery reaches 2 years old, at which point, repeat instructions in step 5.\nPlease ensure all potential users in your facility are made aware of this safety notification and the recommended actions.\nPlease retain this document for your records.\nPlease complete and return the attached acknowledgement form to recall.78101@gehealthcare.com.\n\nGE HealthCare will correct all affected products at no cost to you.\nA GE HealthCare representative will contact you to arrange for the correction.\nAfter the correction has been implemented, please be sure to destroy", "product_quantity": "12,808 total systems", "distribution_pattern": "Worldwide - US Nationwide distribution.", "openfda": { "k_number": [ "K200964", "K160381", "K191798", "K241971", "K212100", "K011315", "K060059", "K032620", "K122825", "K023720", "K102256", "K112451", "K182594", 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