{ "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": "204884", "product_res_number": "Z-0762-2024", "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 Orchide OR Light Systems, Model Numbers and Catalog Numbers OHDII FHD QL VP01 - ARD568803935, OHDII FHD QL AIR03 U - ARD568803952, OHDII FHD QL AIR03 E - ARD568803967, OHDII FHD QL AIR04 E/U - ARD568803968, OHDII FHD QL+ VP01 - ARD569204944, OHDII AIR03 QL FHD E - ARD568803951", "code_info": "All systems affected\n\nUDI-DI: 3700712415761\n3700712415976\n3700712418274\n3700712418281\n3700712412340", "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" ] } } ] }