{ "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": "220061", "product_res_number": "Z-2669-2026", "event_date_initiated": "2026-05-21", "event_date_posted": "2026-07-02", "recall_status": "Open, Classified", "res_event_number": "98876", "product_code": "FFX", "k_numbers": [ "K121014" ], "product_description": "Solar GI System (Water Perfusion); \nProduct Name (Catalog Number): Solar GI LGI H2O, 12p, Trolley system (G3-6), Solar GI HRM H2O, 24p, Compact Pole system (G3-7), Solar GI HRM H2O, 24p, Trolley system (G3-8), Solar GI HRM H2O, 36p, Trolley system (G3-12), Solar GI HRAM H2O, 24p, Trolley system (G3-14);", "code_info": "1. Catalog Number: G3-6; UDI-DI: Primary UDI-DI: 08717775955047; Basic UDI-DI: 87177759500G3G8; All serial numbers;\n2. Catalog Number: G3-7; UDI-DI: Primary UDI-DI: 08717775955054; Basic UDI-DI: 87177759500G3G8; All serial numbers;\n3. Catalog Number: G3-8; UDI-DI: Primary UDI-DI: 08717775955061; Basic UDI-DI: 87177759500G3G8; All serial numbers;\n4. Catalog Number: G3-12; UDI-DI: Primary UDI-DI: 08717775955078; Basic UDI-DI: 87177759500G3G8; All serial numbers;\n5. Catalog Number: G3-14; UDI-DI: Primary UDI-DI: 08717775955085; Basic UDI-DI: 87177759500G3G8; All serial numbers;", "firm_fei_number": "3017448360", "recalling_firm": "Laborie Medical Technologies Corp", "address_1": "180 International Dr", "city": "Portsmouth", "state": "NH", "postal_code": "03801-6837", "additional_info_contact": "Thomas Hirte\n603-570-2675", "reason_for_recall": "Under extended clinical use conditions (e.g., long duration studies), moisture generated within the pneumatic circuit may accumulate inside the system's internal tubing or at the hydrophobic filter and waterproof pressure sensors. Accumulated moisture may affect airflow or pressure measurement performance if not properly removed.", "root_cause_description": "Device Design", "action": "Laborie Medical Technologies notified consignees on about 05/21/2026 via letter. Consignees were instructed to always use the pre-check instructions provided in the IFU to ensure that the device is operating properly, ensure all operators are aware of the outlined IFU updates in the customer notification to include the following: \n1. Updated 3-Minute Blow-Out Moisture Removal Maintenance Procedure (New IFU Section 3.0 and provided in the attached insert).\n2. Laborie has added the following to the revised IFU in addition to the blow-out procedure presented in Attachment 1:\n\" A Device Use Life Statement in Section 1.8.\n\" The statement in Section 2.4.3. \n\nConsignees were also instructed to review the Enclosed IFU Insert Section 3.0 for the updated Blow-Out Moisture Removal Maintenance Procedure and ensure all clinical users are trained to the new maintenance procedure. Laborie recommends that customers print-out the Blow-Out procedure and post it on or near the device for awareness of the change in the Blow-Out Cycle. Distribute this notification and IFU insert to all clinical operators, \nsupervisors and trainers, biomedical engineering / technical support staff, and any personnel responsible for system cleaning, setup, or maintenance.", "product_quantity": "372 units", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bangladesh, Belgium, Canada, China, Costa Rica, Croatia, Cyprus, Czech Republic. Denmark, Egypt, France, Germany, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Libya, Lithuania, Malaysia, Namibia, Nepal, Netherlands. Oman, Osterreich, Pakistan, Poland, Portugal, Puerto Rico, Qatar, Russia, Russian Federation, Saudi Arabia, Serbia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Tunisia, Turkey, UAE, United Kingdom, and Vietnam.", "openfda": { "k_number": [ "K062222", "K010130", "K012232", "K900058", "K880581", "K190208", "K905154", "K181750", "K920664", "K160725", "K831347", "K832869", "K102214", "K082056", "K990441", "K011472", "K151086", "K231861", "K031169", "K003580", "K031084", "K991288", "K121014", "K973844", "K984444", "K120524", "K921682", "K181760", "K252605", "K932306", "K092850", "K874690", "K120997", "K122294", "K000386", "K013154", "K071094", "K991389", "K011471", "K004040", "K102801", "K223705", "K760761", "K942247", "K130906", "K183072", "K191087", "K830421", "K060166", "K091070", "K240007", "K921062", "K222000", "K980980", "K981733", "K780812", "K160170", "K881609", "K980946", "K170833", "K201106", "K823701", "K160287", "K812103", "K992713", "K052338", "K002427", "K963064", "K972439" ], "device_name": "System, Gastrointestinal Motility (Electrical)", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1725", "device_class": "2", "registration_number": [ "8020893", "1836324", "9611896", "2023374", "3016854619", "3012302888", "9611668", "3008717264", "3010381606", "9681384", "3010082909", "3018094310", "3017448360", "3009106214", "3012480535", "1126271", "3016544248", "3008414621", "3004904811", "3013973539", "3035451914", "3009445917", "3015198783", "3002821211", "3008361498", "3007662958", "3011790297", "3002806603", "9710107", "1123137", "1119033" ], "fei_number": [ "3003348376", "1000263641", "2023374", "3016854619", "3012302888", "3009293069", "3008717264", "3010381606", "3010082909", "3018094310", "3017448360", "3009106214", "3012480535", "3002807626", "3016544248", "3008414621", "3004904811", "1000123180", "3013973539", "3035451914", "3015198783", "3002821211", "3008361498", "3007662958", "3002807135", "3002807850", "3011790297", "3002806603", "3002998595", "1119033", "3002957361" ] } } ] }