{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "157831", "product_res_number": "Z-0052-2018", "event_date_initiated": "2017-07-13", "event_date_created": "2017-10-27", "recall_status": "Terminated", "event_date_terminated": "2020-09-15", "res_event_number": "77754", "product_code": "PBX", "k_numbers": [ "K151296" ], "product_description": "THERMI250 Radiofrequency System.\n\nIntended to provide heating for the purpose of elevating tissue temperature for selected medical conditions.", "code_info": "Serial No. TS250-16G-088-1, TS250-16G-089-1, TS250-16G-090-1, TS250-16G-094-1, TS250-16G-097-1, TS250-16G-098-1, TS250-16G-106-1, TS250-16G-109-2, TS250-16I-116-1, TS250-16I-120-1, TS250-16I-121-1, TS250-16I-122-1, TS250-16I-123-1, TS250-16I-124-1, TS250-16I-127-1, TS250-16I-128-1, TS250-16I-129-1, TS250-16I-130-1, TS250-16I-134-1, TS250-16I-135-1, TS250-16I-136-1, TS250-16I-137-1, TS250-16I-140-1, TS250-16I-142-1, TS250-16I-146-2, TS250-16L-156-1, TS250-16L-158-1, TS250-16L-159-1, TS250-16L-160-1, TS250-16L-164-1, TS250-16L-165-1, TS250-16L-167-1, TS250-16L-168-1, TS250-16L-169-1, TS250-16L-170-1, TS250-16L-177-1, TS250-16L-178-1, TS250-16L-179-1, TS250-16N-190-1, TS250-16N-191-1, TS250-16N-192-1, TS250-16N-194-1, TS250-16N-195-1, TS250-16N-197-1, TS250-16N-198-1, TS250-16N-199-1, TS250-16N-202-1, TS250-16N-203-1, TS250-16N-204-1, TS250-16N-205-1, TS250-16N-207-1, TS250-16N-208-1, TS250-16N-209-1, TS250-16N-210-1, TS250-16N-211-1, TS250-16N-213-1, TS250-16N-214-1, TS250-16N-215-1, TS250-16N-216-1, TS250-16N-217-1, TS250-16N-219-1, TS250-16N-220-1, TS250-16N-223-1, TS250-16N-224-1, TS250-17B-229-1, TS250-17B-230-1, TS250-17B-231-1, TS250-17B-239-1, TS250-17B-243-1, TS250-17B-247-1, TS250-17B-249-1, TS250-17B-250-1, TS250-16L-153-1, TS250-16L-180-2, TS250-16N-212-1, TS250-17B-225-1, TS250-17B-226-1, TS250-17B-228-1, TS250-17B-232-1, TS250-17B-233-1, TS250-17B-234-1, TS250-17B-242-1, TS250-17B-245-1, TS250-16G-093-1, TS250-16G-104-1, TS250-16L-182-2, TS250-17B-235-1, TS250-17B-236-1, TS250-17B-237-1, TS250-17B-238-1, TS250-17B-244-1, TS250-16I-112-2, TS250-16I-113-2, TS250-16I-114-2, TS250-16I-115-2, TS250-16G-100-1, TS250-16G-081-1, TS250-16G-082-1, TS250-16G-083-1, TS250-16G-084-1, TS250-16G-085-1, TS250-16G-086-1, TS250-16G-087-1, TS250-16G-091-1, TS250-16G-092-1, TS250-16G-095-1, TS250-16G-096-1, TS250-16G-099-1, TS250-16G-101-1, TS250-16G-102-1, TS250-16G-103-1, TS250-16G-105-1, TS250-16G-107-1, TS250-16H-110-2, TS250-16I-117-1, TS250-16I-118-1, TS250-16I-119-1, TS250-16I-125-1, TS250-16I-126-1, TS250-16I-131-1, TS250-16I-132-1, TS250-16I-133-1, TS250-16I-138-1, TS250-16I-139-1, TS250-16I-141-1, TS250-16I-143-1, TS250-16I-144-2, TS250-16I-145-2, TS250-16I-147-2, TS250-16L-155-1, TS250-16L-176-1, TS250-16L-183-2, TS250-16N-193-1, TS250-16N-196-1, TS250-16N-200-1, TS250-16N-201-1, TS250-16N-206-1, TS250-16N-218-1, TS250-16N-222-1, TS250-17B-227-1, TS250-17B-240-1, TS250-17B-241-1, TS250-17B-246-1, TS250-17B-248-1, TS250-17B-251-1, TS250-17B-252-1, TS250-17B-253-1, TS250-17B-254-1, TS250-17B-255-1, TS250-17B-256-1, TS250-17B-257-1, TS250-17B-258-1, TS250-17B-259-1, TS250-17B-260-1, TS250-16H-108-2, TS250-16L-148-1, TS250-16L-149-1, TS250-16L-150-1, TS250-16L-151-1, TS250-16L-152-1, TS250-16L-157-1, S250-16L-181-2, TS250-16L-184-1, TS250-16L-185-1, TS250-16L-186-1, TS250-16L-187-1, and TS250-16L-188-1", "firm_fei_number": "3008108972", "recalling_firm": "Bios S.r.l.", "address_1": "Via Guido Rossa 10/12 10/12 via guido rossa", "city": "Vimodrone", "country": "Italy", "reason_for_recall": "In some systems, the unit continues to emit RF energy after the PAUSE button is pressed.", "root_cause_description": "Software design", "action": "Consignees were sent a recall notification by mail dated 07/13/2017. Customers were notified of the reason for recall and advised that the PAUSE button not be used and the STOP button be used instead to stop the RF emission. Additionally, units are to be connected to the internet so that the BIOS service team can access the units to provide a software update to correct the issue. If a unit cannot be connected to the internet, customers are to contact Thermi to schedule an update.", "product_quantity": "167 units", "distribution_pattern": "AZ, AR, CA, FL, GA, ID, IL, KS, LA, MA, MI, MS, MO, NV, NJ, NM, NY, OH, OR, PA, SD, TX, WA, WI, and WV\nBrazil, Canada, Israel, Japan, & Thailand.", "openfda": { "k_number": [ "K151296", "K210867", "K183371", "K241107", "K161199", "K181893", "K213256", "K171052", "K221043", "K252888", "K223907", "K190743", "K242553", "K122389", "K210129", "K243164", "K150035", "K202780", "K220592", "K181095", "K253261", "K230659", "K211461", "K182094", "K160329", "K161551", "K213295", "K191202", "K214015", "K153568", "K162512", "K191940", "K241733", "K190023", "K211207", "K213308", "K200468", "K232966", "K242175", "K191855", "K230037", "K240991", "K202247", "K162828", "K243055", "K260647", "K172004", "K250916", "K172302", "K243716", "K143554", "K170637", "K230412", "K253480", "K133739", "K220014", "K183693", "K181211", "K180709", "K214090", "K212253", "K163176", "K200241", "K143040", "K210877", "K242598", "K240178", "K132949", "K211091", "K230755", "K161458", "K222260", "K161043", "K150720", "K201064", "K183450", "K201475", "K250734", "K200359" ], "registration_number": [ "", "3010836847", "3016413636", "3038715747", "3006153348", "3015452693", "1222993", "8010720", "3017954802", "3026400760", "3030420005", "3038280308", "3018994966", "3015283772", "3008915316", "3016746323", "3010363436", "1725006", "3010226575", "3008753275", "3011307265", "3015779311", "3023339107", "3008929787", "3004784537", "3013539104", "3006850277", "3017263740", "3013734919", "3013652305", "3004940677", "3007544634", "3016496662", "3013517192", "3005695724", "3007645866", "9612147", "3016446653", "3030230686", "3007491751", "3036425107", "3043140693", "3022747124", "3011670002", "3007712511", "3044778118", "2087572", "3002808227", "3010511300", "3035374386", "3006807694", "3008729892", "3043657394", "3010402752", "3016512343", "9680721", "3016675013", "3013917867", "8040537", "2954354", "3008085016", "3011070163", "3007421149", "3011782009", "3013602304", "3021177911", "3016087653", "3015433394", "8040510", "3009736547", "3045753434", "3001431138" ], "fei_number": [ "", "3010836847", "3016413636", "3038715747", "3006153348", "3015452693", "3005154439", "7759", "3017954802", "3026400760", "3030420005", "3038280308", "3018994966", "3015283772", "3008915316", "3016746323", "3010363436", "3000140642", "3008108972", "3010226575", "3008753275", "3011307265", "3015779311", "3023339107", "3008929787", "3004784537", "3013539104", "3006850277", "3017263740", "3013734919", "3013652305", "3007544634", "3016496662", "3013517192", "3005695724", "3007645866", "3002807555", "3016446653", "3030230686", "3007491751", "3036425107", "3043140693", "3022747124", "3011670002", "3001319476", "3002900199", "3044778118", "3007712511", "3002808227", "3035374386", "3010511300", "3003258642", "3006807694", "3043657394", "3010402752", "3002806913", "3016512343", "3010666513", "3016675013", "3013917867", "1000244733", "3008085016", "3011070163", "3007421149", "1000120578", "3013602304", "3021177911", "3016087653", "3015433394", "3009736547", "3045753434", "3001431138" ], "device_name": "Massager, Vacuum, Radio Frequency Induced Heat", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4400", "device_class": "2" } } ] }