{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "85585", "product_res_number": "Z-0414-2010", "event_date_initiated": "2009-09-11", "event_date_posted": "2009-11-23", "recall_status": "Terminated", "event_date_terminated": "2012-03-01", "res_event_number": "53475", "product_code": "FTD", "k_numbers": [ "K010724" ], "product_description": "STERIS Harmony LL 500/700 Surgical Light, Vertical Spring-Loaded Arm.\n\nIntended for local illumination of the operating and examination area of the patient in treatment rooms.", "code_info": "Part Number: YG18568; Serial Numbers: Year 2002 - 0111 072 XXXXX to 0111 122 XXXXX; Year 2003-0111 013 XXXXX to 0111 123 XXXXX; Year 2004-0111 014 XXXXX to 0111 124 XXXXX; Year 2005-0111 015 XXXXX to 0111 125 XXXXX; and Year 2006-0111 016 XXXXX to 0111 066 XXXXX - (XXXXX means every 5-digit serial number).", "firm_fei_number": "1527821", "recalling_firm": "Steris Corp", "address_1": "5960 Heisley Rd", "city": "Mentor", "state": "OH", "postal_code": "44060", "additional_info_contact": "Barbara Rich\n440-392-7318", "reason_for_recall": "Drger Medical AG & Co., KGaA informed STERIS Corporation that they received (4) reported international cases where a welded seam at the joint of the spring-loaded arm of the Drger SOLA 500/700 surgical light broke as a result of a crack that had slowly developed over time. The STERIS Harmony LL 500/700 surgical light is a Private Label version of the Drger SOLA 500/700 surgical light.", "root_cause_description": "Device Design", "action": "The firm sent Urgent Product Correction letters, dated Sept. 11, 2009, to their customers. The letter identified the problem and stated that Drager had supplied STERIS the replacement spring arms and that a STERIS Service Technician would perform the replacement. The letter also stated that the correction would be performed at no charge to the customers. According to the letter, customers would be contacted by their STERIS Service Representative to arrange a convenient time for replacement of potentially affected spring arms. In the meantime, the letter states that customers should use their surgical lights in accordance with the guidelines presented in the Operator's Manual. Questions or concerns regarding the letter should be directed to Barbara Rich at 440-392-7318 or your local STERIS account manager.", "product_quantity": "388 units", "distribution_pattern": "Worldwide Distribution -- USA, including the states of AL, AR, CA, CO, CT, FL, GA, HI, IL, IN, KS, LA, MA, MN, MO, MS, NC, NH, NJ, NV, NY, OH, PA, RI, SC, TN, TX, UT, VA, WA, WI & WY and the country of Canada.", "openfda": { "k_number": [ "K932451", "K003423", "K133425", "K770568", "K041681", "K823360", "K123776", "K053364", "K961122", "K801353", "K841360", "K931675", "K770861", "K130513", "K930897", "K100884", "K981717", "K111020", "K942553", "K811728", "K071180", "K010724", "K770567", "K895715", "K954263", "K100234", "K013242", "K882613", "K860088" ], "registration_number": [ "", "3009715914", "1037039", "3019729879", "3008610343", "3010421104", "3000286616", "1000122786", "3001104093", "3008716327", "3009905888", "3016904853", "3027847726", "1066635", "3008808049", "9614609", "3012092534", "8031020", "2648666", "3017815086", "8044093", "3006467297", "3005977121", "3033433849", "1047843", "1043214", "3004361444", "3017265430", "3013115071", "3003882387", "3031563141", "3015978022", "1066427", "3007836437", "3016590299", "9710055", "3010373494", "3004137296", "3015444963", "3010273872", "3004187094", "3009631939", "2030624", "2650143", "3010041511", "3011580044", "9611500", "3015729", "3011137372", "3011910987", "3005726841", "3011706110", "3008538162", "2528981", "9681407", "8010177", "3007143268", "3003707320", "3013524663", "3017970309" ], "fei_number": [ "", "3007513035", "3009715914", "1037039", "3005747797", "3023530182", "3019729879", "3008610343", "3010421104", "3000286616", "1000122786", "3001104093", "3008716327", "3009905888", "3016904853", "3027847726", "2648666", "3008808049", "3002732397", "3003184737", "3017815086", "3006467297", "3005729015", "3005977121", "3002807830", "3033433849", "2648209", "1047843", "1043214", "3004361444", "3017265430", "3013115071", "3003882387", "3031563141", "3015978022", "3002465150", "3007836437", "3016590299", "3010373494", "3004137296", "3015444963", "3010273872", "3000206435", "3004187094", "3009631939", "3010041511", "3011580044", "1000182014", "3015729", "3011910987", "3005726841", "3025504317", "3011706110", "3008538162", "2528981", "3002821504", "3007143268", "3003707320", "3013524663", "3017970309" ], "device_name": "Lamp, Surgical", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4580", "device_class": "2" } } ] }