{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "204883", "product_res_number": "Z-0761-2024", "event_date_initiated": "2023-11-08", "event_date_posted": "2024-01-19", "recall_status": "Open, Classified", "res_event_number": "93567", "product_code": "FTD", "product_description": "Maquet Equipment OR Light Systems, Model Numbers and Catalog Numbers BRAINLAB CAMERA - ARDEQT269000A, BRAINLAB CAMERA - ARDEQT269000C, BRAINLAB CAMERA - ARDEQT269001A, BRAINLAB CAMERA - ARDEQT269001C, BRAINLAB CAMERA - ARDEQT269004A, BRAINLAB CAMERA - ARDEQT269004C, BRAINLAB CAMERA - ARDEQT269005A, BRAINLAB CAMERA - ARDEQT269005C, EQTBRB SAT12 - ARDSAT269000A, EQTBRB SAT13 - ARDSAT269001A, EQTFHS010 11 - ARDEQT239014A, EQTFHS010 SAT12 - ARDSAT239005A, EQTFHS010 SAT13 - ARDSAT239006A, EQTFHS010 SAT16 - ARDSAT239023A, EQTMHD231 - ARDEQT239013A, EQTMHD231 11 - ARDEQT239016A, EQTMHD231 16 - ARDEQT239023A, EQTMHD231 SAT12 - ARDSAT239013A, EQTMHD231 SAT13 - ARDSAT239014A, EQTMHS013 08 - ARD2EQT00010A, EQTMHS013 11 - ARDEQT239007A, EQTMHS013 14 - ARDEQT239008A, EQTMHS013 16 - ARDEQT239009A, EQTMHS013 SAT12 - ARDSAT239007A, EQTMHS013 SAT13 - ARDSAT239008A, EQTMHS021 11 - ARDEQT239010A, EQTMHS021 14 - ARDEQT239011A, EQTMHS021 16 - ARDEQT239012A, EQTMHS021 SAT12 - ARDSAT239009A, EQTMHS021 SAT13 - ARDSAT239010A, EQTSC07 SAT12 - ARD515031140A, EQTSC07 SAT13 - ARD515032140A, EQTSC07 SAT16 - ARD2SAT00120A, EQTSC07 SAT16 - ARDSAT229007A, EQTSHD 11 - ARDEQT229001A, EQTSHD SAT - ARD515031990A, EQTSHD SAT - ARD515032990A, EQTSPC12 08 - ARDEQT269008A, EQTSPC12 11 - ARDEQT269009A, EQTSPC12 SAT12 - ARDSAT269005A, EQTSPC12 SAT13 - ARDSAT269006A, EQTXHD127 08 - ARDEQT239026A, EQTXHD127 11 - ARDEQT239027A, EQTXHD127 16 - ARDEQT239028A, EQTXHD127 SAT12 - ARDSAT239021A, EQTXHD127 SAT13 - ARDSAT239022A, EQTXHS010 08 - ARD2EQT00030A, EQTXHS010 08 - ARDEQT239024A, EQTXHS010 10 - ARD2EQT00050A, EQTXHS010 11 - ARDEQT239017A, EQTXHS010 14 - ARDEQT239019A, EQTXHS010 16 - ARDEQT239020A, EQTXHS010 SAT12 - ARDSAT239015A, EQTXHS010 SAT13 - ARDSAT239018A, EQTXHS021 08 - ARDEQT239025A, EQTXHS021 11 - ARDEQT239018A, EQTXHS021 14 - ARDEQT239021A, EQTXHS021 16 - ARDEQT239022A, EQTXHS021 SAT12 - ARDSAT239019A, EQTXHS021 SAT13 - ARDSAT239020A, EQTXS3216 11 - ARDEQT239015A, EQTXS3216 SAT12 - ARDSAT239016A, EQTXS3216 SAT13 - ARDSAT239017A, HOR 14 XD2 - ARDEQT239006A, HOR 14 XD2 - ARDEQT239006C, HOR 14 XO - ARDEQT269002A, HOR 14 XO - ARDEQT269002C, HOR 14 XS0 - ARDEQT239004A, HOR 14 XS0 - ARDEQT239004C, HOR 14 XS1 - ARDEQT239005A, HOR 14 XS1 - ARDEQT239005C, HOR 16 XD2 - ARDEQT239003A, HOR 16 XD2 - ARDEQT239003C, HOR 16 XO - ARD267900080A, HOR 16 XO - ARDEQT269003A, HOR 16 XO - ARDEQT269003C, HOR 16 XS0 - ARDEQT239001A, HOR 16 XS0 - ARDEQT239001C, HOR 16 XS1 - ARDEQT239002A, HOR 16 XS1 - ARDEQT239002C, SAT BRAINLAB 12 - ARD515070110A, SAT BRAINLAB 12 - ARD515070110C, SAT BRAINLAB 13 - ARD515071110A, SAT BRAINLAB 13 - ARD515071110C, SAT BRAINLAB CAMERA - ARDSAT269000C, SAT BRAINLAB CAMERA - ARDSAT269001C, SAT BRAINLAB CAMERA - ARDSAT269003A, SAT BRAINLAB CAMERA - ARDSAT269003C, SAT BRAINLAB CAMERA - ARDSAT269004A, SAT BRAINLAB CAMERA - ARDSAT269004C, SAT CAM 12 - ARD515031880A, SAT CAM 12 - ARD515031880C, SAT CAM 13 - ARD515032880A, SAT CAM 13 - ARD515032880C, SAT MEDIA - ARD2SAT00210A, SAT MEDIA - ARD2SAT00220A, SAT MHD214 - ARDSAT239011A, SAT MHD214 - ARDSAT239012A, SAT ORCHID - ARDSAT229000A, SAT ORCHID - ARDSAT229000C, SAT ORCHID - ARDSAT229001A, SAT ORCHID - ARDSAT229001C, SAT ORCHID - ARDSAT229003A, SAT ORCHID - ARDSAT229003C, SAT ORCHID - ARDSAT229004A, SAT ORCHID - ARDSAT229004C, SAT ORCHIDE 12 - ARD515031991A, SAT ORCHIDE 12 - ARD515031991C, SAT ORCHIDE 12 - ARDSAT229005A, SAT ORCHIDE 12 - ARDSAT229005C, SAT ORCHIDE 13 - ARD515032991A, SAT ORCHIDE 13 - ARD515032991C, SAT ORCHIDE 13 - ARDSAT229006A, SAT ORCHIDE 13 - ARDSAT229006C, SAT PERF 258S - ARD515053130A, SAT PERF 258S - ARD515053130C, SAT SC 071 - ARD515031140C, SAT SC 071 - ARD515032140C, SAT SC07 HOR - ARD2SAT00120C, SAT SHD 12 - ARD515031990C, SAT SHD 13 - ARD515032990C, SAT SHD HOR - ARD2SAT00150A, SAT SHD HOR - ARD2SAT00150C, SAT SSD 13 - ARD515032080A, SAT SUP CAM 12 - ARD515031730A, SAT SUP CAM 13 - ARD515032730A, SAT XD 241 - ARD515031660A, SAT XD 241 - ARD515031660C, SAT XD 241 - ARD515032660A, SAT X", "code_info": "All systems affected\n\nUDI-DI: 03700712400583\n\n\n\n03700712400606\n\n03700712400590\n\n3700712401252\n3700712401269\n3700712414184\n3700712411855\n3700712411862\n3700712420208\n\n3700712415778\n3700712417123\n3700712411916\n3700712411923\n3700712415822\n3700712414177\n3700712417154\n3700712417161\n3700712411879\n3700712411886\n3700712414160\n3700712417130\n3700712417147\n3700712411893\n3700712411909\n3700712401092\n3700712401108\n03700712405946\n3700712416829\n\n3700712416805\n3700712416812\n3700712421076\n3700712421083\n3700712421090\n3700712421106\n3700712417253\n3700712417260\n3700712417277\n3700712417239\n3700712417246\n03700712417031\n3700712420130\n03700712417048\n3700712416072\n3700712416997\n3700712417000\n3700712416126\n3700712416119\n3700712420147\n3700712416065\n3700712417017\n3700712417024\n3700712416096\n3700712416102\n3700712414306\n3700712414283\n3700712414290\n3700712400972\n\n3700712400989\n\n3700712400996\n\n3700712401009\n\n03700712401016\n\n\n3700712401023\n\n3700712401030\n\n3700712401047\n\n\n\n\n\n\n\n\n\n\n\n03700712401078\n\n03700712401085\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n3700712401191\n\n3700712401207\n\n\n\n\n\n\n\n03700712417178\n3700712401276\n\n3700712419349\n3700712401283\n\n\n\n\n3700712400057\n\n3700712401221\n\n03700712405915\n03700712405908\n3700712400132\n\n3700712401245\n\n\n\n\n03700712406073\n\n03700712406059\n\n\n3700712401054\n\n\n\n3700712420178\n3700712401061\n\n3700712406042\n\n3700712422240\n3700712422257\n3700712422264\n3700712421427\n3700712422271\n3700712422288\n3700712421403\n3700712422295\n3700712422301\n3700712422318\n3700712422325\n3700712422332\n3700712422349\n3700712422356\n3700712422363\n3700712422370\n3700712421441\n3700712422387\n3700712422394\n3700712421465\n3700712422400\n3700712422417\n3700712421496\n3700712422424\n3700712421472\n3700712422431\n3700712422448\n3700712421489\n3700712422455\n3700712422462\n3700712422479\n3700712421410\n3700712422486\n3700712422493\n3700712422509\n3700712421458\n3700712421434\n3700712422516\n3700712422523\n3700712422530\n3700712422547\n3700712422554\n3700712422561\n3700712422578\n3700712422585\n3700712422592", "firm_fei_number": "3013876692", "recalling_firm": "Getinge Usa Sales Inc", "address_1": "1 Geoffrey Way", "city": "Wayne", "state": "NJ", "postal_code": "07470-2035", "additional_info_contact": "Jessica Minaya\n973-709-7634", "reason_for_recall": "A potential for a light system to fall in the operating room.", "root_cause_description": "Equipment maintenance", "action": "An URGENT MEDICAL DEVICE CORRECTION letter dated 11/8/23 was sent to customers.\n\nActions to be taken by the customer:\nOur records indicate that you have been identified as having purchased at least one model of one of these product ranges. Please identify your affected units using the referenced devices on page 1 and follow the instructions below.\n\nPlease distribute this notice and forward the link below to access manuals to anyone\nwithin your organization who may need to use the manuals, and especially to your\nservice or service provider who performs your maintenance.\n\nLight system fixing and other replacements:\nRegarding:\n- the fixing of the light systems: suspensions fixing screws, adapter fixing screws, bushing fixing screws\n- the brake screws\n- the safety segments\n- the batteries, a dedicated instruction to illustrate and facilitate understanding of what to replace and what to order for replacement has been issued.\n\nThe instruction is available on a dedicated space on the web portal\nhttps://www.getinge.com/int/campaigns/maintenance-and-service-on-or-light-system/,\nand provided upon request by emailing MSA808092.sw@getinge.com\nShould you have questions or require additional information, please do not hesitate to contact Maquet SAS/Getinge or your local representative.\n\nPlease complete and sign the attached MEDICAL DEVICE CORRECTION - RESPONSE\nFORM (page 7) to acknowledge that you have received this notification. Return the completed form to Maquet/Getinge by e-mailing a scanned copy to\nor-lights2023.qrc@getinge.com or by faxing the form to (866) 350-0897.\nIf you are a distributor who has shipped any affected products to customers, please\nforward this document to their attention for appropriate action.\n\nActions to be taken by Maquet SAS / Getinge:\nAs the majority of customers may not have regular contact with Getinge services or authorized Getinge representatives and therefore may not be aware of current maintenance recommendations, Maquet SAS/Getinge is providin", "product_quantity": "236793 units in total", "distribution_pattern": "US Nationwide. Global Distribution.", "openfda": { "k_number": [ "K841360", "K961122", "K003423", "K860088", "K895715", "K823360", "K770568", "K931675", "K010724", "K932451", "K770861", "K942553", "K130513", "K013242", "K811728", "K053364", "K100234", "K981717", "K801353", "K954263", "K123776", "K111020", "K071180", "K882613", "K041681", "K930897", "K100884", "K133425", "K770567" ], "device_name": "Lamp, Surgical", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4580", "device_class": "2", "registration_number": [ "", "3006467297", "9611500", "3031563141", "3008610343", "3017265430", "3017970309", "3008808049", "3010041511", "3005977121", "3011910987", "3011580044", "3016904853", "3001104093", "3010421104", "2650143", "3011706110", "3009905888", "3003707320", "8044093", "1000122786", "3007143268", "3004361444", "3012092534", "3011137372", "3008538162", "3016590299", "3015978022", "3005726841", "2030624", "1043214", "8031020", "3003882387", "3010373494", "1047843", "3017815086", "2528981", "1066635", "3010273872", "8010177", "3015729", "3009715914", "9681407", "3013115071", "3004137296", "3019729879", "3027847726", "9710055", "1066427", "3000286616", "3009631939", "3008716327", "3013524663", "3015444963", "3033433849", "9614609", "3004187094", "1037039", "3007836437", "2648666" ], "fei_number": [ "", "3002732397", "1000182014", "3006467297", "3031563141", "3008610343", "3017265430", "3017970309", "3008808049", "3005729015", "3010041511", "3005977121", "3011910987", "3011580044", "3023530182", "3016904853", "3010421104", "3001104093", "3011706110", "3009905888", "3003707320", "1000122786", "3002465150", "3007143268", "3004361444", "3008538162", "3016590299", "3015978022", "3005726841", "3007513035", "1043214", "3000206435", "3003882387", "3010373494", "1047843", "3017815086", "2528981", "3010273872", "3015729", "3009715914", "3005747797", "3013115071", "3004137296", "3019729879", "3027847726", "3003184737", "3025504317", "3000286616", "3009631939", "3008716327", "3013524663", "3015444963", "3033433849", "3004187094", "1037039", "2648209", "3007836437", "2648666", "3002821504", "3002807830" ] } } ] }