{ "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": "122654", "product_res_number": "Z-0851-2014", "event_date_initiated": "2013-10-07", "event_date_posted": "2014-01-28", "recall_status": "Terminated", "event_date_terminated": "2014-08-27", "res_event_number": "66585", "product_code": "JJE", "k_numbers": [ "K051087" ], "product_description": "User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System with software version 3.5.1 or lower\n\nUser Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids.", "code_info": "Material numbers 10284473, 10488224, 10444801, and 10444802.", "firm_fei_number": "2517506", "recalling_firm": "Siemens Healthcare Diagnostics, Inc.", "address_1": "500 Gbc Dr Ms 514", "address_2": "PO BOX 6101", "city": "Newark", "state": "DE", "postal_code": "19702-2466", "additional_info_contact": "Customer Support\n800-441-9250", "reason_for_recall": "When utilizing the Routine Inventory screen to enter a User Defined Method (EMPTY) Flex the system may assign the User Defined Method Flex to a different Flex that is currently in inventory on the system, and then use the incorrect Flex Cartridge to process the user defined method.", "root_cause_description": "Software design", "action": "Siemens sent a Urgent Medical Device Correction letter dated October 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. \n\nPlease use the following actions if using Vista SW Versions 3.5.1 and below to prevent the issue from occurring:\n1. When assigning a User Defined (EMPTY) Flex, use the Advanced Inventory Screen per the Operators Guide.\n2. Verify that EMPTY Flex is no longer listed in the inventory before proceeding with any testing.\n3. If the EMPTY Flex is still listed in the inventory, contact your Siemens Customer Care Center - Technical Solutions for assistance.\n\nPlease retain this letter with your laboratory records and forward this letter to those who may have received this product. Discuss the content of this letter with your Medical Director.\n\nWe apologize for the inconvenience this situation has caused. If you have any questions, please contact your Siemens Customer Care Center - Technical Solutions at (800-441-9250) or your local Siemens technical support representative.", "product_quantity": "2038", "distribution_pattern": "USA (nationwide) Distribution including Puerto Rico.", "openfda": { "k_number": [ "K965240", "K862235", "K872494", "K832584", "K003721", "K800572", "K823762", "K890927", "K051087", "K963539", "K961274", "K961142", "K841916", "K073370", "K833833", "K852133", "K823386", "K882307", "K840883", "K040958", "K974779", "K915106", "K864849", "K780464", "K833448", "K854138", "K771245", "K782014", "K834534", "K852262", "K883539", "K942443", "K873617", "K953239", "K802320", "K800085", "K890928", "K820888", "K855196", "K950915", "K063144", "K912844", "K822465", "K130915", "K820687", "K002982", "K790072", "K853391", "K853699", "K840129", "K885289", "K860021", "K962235", "K010500", "K861055", "K843283", "K813102", "K854025", "K810596", "K771345", "K800053", "K923579", 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