{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "198100", "product_res_number": "Z-1136-2023", "event_date_initiated": "2023-01-16", "event_date_posted": "2023-02-13", "recall_status": "Open, Classified", "res_event_number": "91518", "product_code": "KPS", "k_numbers": [ "K193248" ], "product_description": "SIEMENS Biograph Vision: a) 450, b) 600, c) 600 Edge", "code_info": "a) 450: UDI/DI 405686923807410106, Material Number 10749669, Serial Number 10106; \nb) 600: UDI/DI 405686922450311120, Material Number 10749670, Serial Number 11120; \nUDI/DI 405686922450311116, Material Number 10749670, Serial Number 11116; \nc) 600 Edge: UDI/DI 405686918321311068, Material Number 10749672, Serial Number 11068", "firm_fei_number": "1000514697", "recalling_firm": "Siemens Medical Solutions USA, Inc.", "address_1": "2501 Barrington Rd", "city": "Hoffman Estates", "state": "IL", "postal_code": "60192-2061", "additional_info_contact": "Siemens Healthineers Representative\n800-888-7436", "reason_for_recall": "This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position.", "root_cause_description": "Process control", "action": "SIEMENS Healthineers distributed a Consumer Safety Advisory Notice to its consignees on 01/16/2023 by mail and email. The notice explained the issue and recommended that the following preventive actions be taken until a local Siemens Healthineers service representative has applied the correction: \n\"Mitigation for Biograph Mobile Installations\n Ensure that the PET/CT Gantry offset protocol is performed every time the coach has moved. If the PET/CT gantry offset fails due to the results being out of tolerance, please cease clinical operations on the system and contact your local Siemens Healthineers service representative for further evaluation and guidance on how to proceed. Information on how to acquire the PET/CT Gantry offset protocol is documented in your user documentation.\nMitigation for Biograph Seismic Installations\n In the event of a seismic event, contact your local Siemens Healthineers service representative for further evaluation and guidance on how to proceed.\nSiemens Healthineers will begin dispatching customer service engineers by the end of February 2023 to inspect and make corrections to the locking mechanism to prevent the occurrence of this issue. The resolution for this issue will be delivered by the following Update Instruction: MI516/22/S.\nPlease ensure that this notice is placed in the Biograph Operator Manual and disseminated to all operators of the scanner.\"\n\n\"If you have any questions regarding this advisory notice, please contact your local Siemens Healthineers representative at the contact numbers provided below.\n America: 1-800-888-7436\n Europe, Middle East, and Africa: +49 9131 940 4000\n Asia and Australia: +86 (21) 3811 2121\"", "product_quantity": "4 units", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Japan, Chile, Australia.", "openfda": { "k_number": [ "K060631", "K173578", "K942146", "K896458", "K963162", "K960192", "K241751", "K233677", "K090178", "K982387", "K934722", "K964712", "K850416", "K960865", "K981352", "K210173", "K050559", "K942116", "K173547", "K963983", "K023768", "K021656", "K181343", "K181468", "K193152", "K123737", "K030199", "K043441", "K231102", 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