{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "190077", "product_res_number": "Z-0333-2022", "event_date_initiated": "2021-10-25", "event_date_created": "2021-12-03", "recall_status": "Open, Classified", "res_event_number": "88944", "product_code": "FFK", "k_numbers": [ "K130368" ], "product_description": "Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter, REF M005466800.\n\nThe device is designed to be used with Northgate Technologies Inc. bipolar disposable EHL probes for the fragmentation of calculi.", "code_info": "All serial number revisions for the following bracketed base serial numbers distributed between 2/14/2017 and 10/7/2021: \n\n21578LAA to 21627LAA\n21628BBA to 21662BBA\n21667CBA to 21689CBA; 21691CBA to 21697CBA; 21699CBA to 21716CBA\n21690CBA, 21698CBA, 21721DBA to 21732DBA; 21734DBA to 21747DBA; 21749DBA to 21756DBA; 21758DBA to 21763DBA; 21765DBA to 21770DBA\n21733DBA, 21748DBA, 21757DBA, 21764DBA, 21771EBA to 21781EBA; 21783EBA to 21787EBA; 21789EBA, 21790EBA, 21792EBA to 21800EBA; 21804EBA to 21820EBA\n21782EBA, 21788EBA, 21791EBA, 21801EBA to 21803EBA; 21821FBA to 21874FBA \n21883HBB to 21942HBB\n21954IBB to 22025IBB\n22026IBB to 22073IBB\n22074IBB to 22130KBB; 22133KBB\n22131KBB\n22134LBB to 22157LBB\n22158ACB to 22229ACB\n22230ACB to 22249ACB\n22250BCB to 22321BCB\n22322CCB to 22393CCB\n22394CCB to 22441CCB\n22453ECB to 22476ECB\n22477FCB to 22488FCB\n22489GCB to 22500GCB\n22511HCB to 22534HCB\n22535ICB to 22558ICB\n22559JCB to 22564JCB; 22570JCB to 22575JCB\n22566JCB to 22569JCB; 22576JCB, 22577JCB, 22579JCB, 22581JCB to 22585JCB\n22565JCB, 22578JCB, 22580JCB, 22586JCB to 22588JCB; 22590JCB to 22593JCB; 22595JCB, 22598JCB\n22597JCB, 22600JCB to 22603JCB; 22607JCB to 22609JCB; 22611JCB, 22614JCB, 22615JCB, 22623JCB\n22589JCB, 22594JCB, 22596JCB, 22599JCB, 22604JCB, 22606JCB, 22610JCB, 22612JCB, 22613JCB, 22616JCB to 22618JCB\n22605JCB, 22619JCB to 22622JCB; 22624JCB to 22630JCB\n22637KCB, 22638KCB, 22640KCB to 22666KCB; 22669KCB, 22671KCB to 22637KCB; 22677KCB, 22678KCB, 22680KCB\n22636KCB, 22639KCB, 22639KCB to 22668KCB; 22670KCB to 22676KCB; 22679KCB, 22681KCB to 22707KCB\n22632KCC to 22635KCC; 22708LCC to 22751LCC\n22752ADC to 22799ADC\n22800BDC to 22895BDC\n22896CDC to 22943CDC\n22944EDC to 22991EDC\n22992FDC to 23039FDC\n23040GDC to 23087GDC\n23088IDD to 23135IDD\n23136JDD to 23183JDD\n23184KDD to 23231KDD\n23232LDD to 23279LDD\n23280AED to 23327AED\n23328CED to 23375CED\n23376DED to 23406DED; 23408DED to 23413DED; 23415DED, 23416DED, 23419DED, 23420DED, 23432DED, 23436DED to 23441DED\n23407DED, 23414DED, 23417DED, 23418DED; 23421DED to 23431DED; 23433DED to 23435DED; 23442DED to 23471DED\n23472HED to 23519HED\n23520IED to 23567IED\n23568KED to 23615KED\n23616AFD to 23627AFD\n23628AFD to 23663AFD\n23664CFE to 23711CFE\n23712DFE to 23759DFE\n23760EFE to 23807EFE\n23808GFE to 23855GFE\n23856HFE to 23867HFE\n23868IFE to 23879IFE\n23880IFE to 23894IFE; 23896IFE to 23899IFE; 23902IFE to 23904IFE; 23907IFE, 23908IFE\n\nGTIN 00817183020493, UDI 00817183020493.", "firm_fei_number": "1450997", "recalling_firm": "Northgate Technologies, Inc.", "address_1": "1591 Scottsdale Ct", "city": "Elgin", "state": "IL", "postal_code": "60123-9361", "additional_info_contact": "Ms. Laura MacMillian\n800-348-0424", "reason_for_recall": "The languages for Russian, Romanian, Slovak, and Czech have the power settings for high and low switched in the device.", "root_cause_description": "Software design (manufacturing process)", "action": "The recalling firm, Northgate Technologies Inc., issued a recall letter dated 10/25/2021 to their customer explaining the reason for recall. The customer was requested to determine the location of the affected devices. If the device is/could be used in one of the affected languages, the device is to be returned so the software can be updated to address the text mix-up. If the device is not or will not be operated in the affected languages, the device does not need to be returned immediately and the software will be upgraded during the next servicing to address the mix-up. Complete the enclosed Recall Acknowledgment Form indicating the serial numbers, distribution dates, and whether the device needs correction now or later and email it to: customerservice@ntisurgical.com.\n\nIn addition, if you have further distributed this product, please identify your customers and notify them at once of this product recall.\n\nIf you have any questions, please contact me at (224) 856-2250 or by e-mail, tgatto@ntisurgical.com.", "product_quantity": "2,277 devices", "distribution_pattern": "US Distribution to state of MA.", "openfda": { "k_number": [ "K885255", "K931755", "K920410", "K011848", "K973788", "K822644", "K944571", "K062475", "K111058", "K863642", "K011911", "K802322", "K914516", "K830086", "K903337", "K160198", "K914515", "K894704", "K002084", "K895178", "K052135", "K191124", "K981233", "K992251", "K243032", "K914517", "K072422", "K202813", "K890436", "K913955", "K834228", "K012445", "K980492", "K974164", "K123038", "K130368", "K162119", "K905553", "K923822", "K092033", "K914514", "K931779", "K242888", "K974796", "K132795", "K822585", "K883189", "K963285", "K913487", "K011065", "K951531", "K852874", "K880503", "K992114", "K230488", "K864904", "K925396", "K120303", "K990341", "K832566", "K102169" ], "registration_number": [ "1828132", "1450997", "9611102", "3011050570", "1225687", "9614434", "3005987240", "1000121056", "3002807616", "2124215", "1314417", "2028632", "1423662", "2020550", "9681260", "3010202439", "3003790304", "3010707607", "8030987", "3005099803", "9610617", "2183744", "2528981", "1648564", "3006546082", "3004096429", "3006617533", "3014342096", "1418479", "3009217531", "1519132", "3009543101", "1820334", "3034630389", "1000161819", "1825146" ], "fei_number": [ "1828132", "1450997", "3011050570", "3002808273", "3000205943", "3005987240", "1000121056", "3007475226", "3002807616", "2124215", "1314417", "3002808001", "1000125025", "2020550", "3003790304", "3010707607", "3005099803", "3002808268", "3000215273", "2183744", "2528981", "3006546082", "3004096429", "3002806565", "3006617533", "3014342096", "1418479", "3009217531", "1519132", "3002806910", "3009543101", "1820334", "3034630389", "1000161819", "3001451463", "1825146" ], "device_name": "Lithotriptor, Electro-Hydraulic", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.4480", "device_class": "2" } } ] }