Medical Device Data System
FDA product code OUG · Class I (low risk) · 21 CFR 880.6310 · General Hospital
A medical device data system (mdds) is a device that is intended to provide one or more of the following uses, without controlling or altering the functions or parameters of any connected medical devices: (i) the electronic transfer of medical device data; (ii) the electronic storage of medical device data; (iii) the electronic conversion of medical device data from one format to another format in accordance with a preset specification; or (iv) the electronic display of medical device data. (2) An MDDS may include software, electronic or electrical hardware such as a physical communications medium (including wireless hardware), modems, interfaces, and a communications protocol. This identification does not include devices intended to be used in connection with active patient monitoring.
1510(k) clearances
0PMA approvals
24recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K122361 | T:Connect Data Management SystemOUG · Traditional | Tandem Diabetes Care, Inc. | 02/22/2013SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1394-2023 Class II | AQURE REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 The AQURE system is…Due to potential software issue that may result in patient mix-up information. | Radiometer Medical ApS | 03/08/2023Open, Classified |
| Z-1201-2023 Class II | MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects…For users with MYLA V4.8.X / V4.9 that use VITEK MS to identify organisms as part of their workflow, AST… | Biomerieux Inc | 02/06/2023Open, Classified |
| Z-0084-2022 Class II | MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO SystemUnder certain conditions, there is a risk for a false negative result. | BioMerieux SA | 09/02/2021Terminated |
| Z-0293-2021 Class II | 9310HD Digital Video Capture Module with software version 3.4.0 or higher configured…There is an intermittent software issue that could affect the systems, in which an exam video for one… | Pentax of America Inc | 09/22/2020Terminated |
| Z-0292-2021 Class II | 9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal),There is an intermittent software issue that could affect the systems, in which an exam video for one… | Pentax of America Inc | 09/22/2020Terminated |
| Z-1673-2020 Class II | LabPro Data Management System, UDI: 15099590676872 - Product Usage: The LabPro Data…A security-only update was released via remote diagnostics on January 14, 2020 to customers with Windows 7… | Beckman Coulter Inc. | 01/17/2020Terminated |
| Z-0542-2020 Class II | myCordella Patient Kit without ECG, The Cordella System is a comprehensive at-home heart…The firm have received reports of patients myCordella Hubs fully powering themselves down without… | Endotronix | 09/25/2019Terminated |
| Z-0864-2020 Class II | AQURE basic sytem, FLEXLINK, REF 933-599, Version: 2.3.3 (17), CE IVD, Rx Only, UDI:…The firm has become aware that there is a potential problem relating to the blood gas and immunoassay… | Radiometer Medical ApS | 08/08/2019Terminated |
| Z-2223-2019 Class II | The Visibly Online Refractive Vision Test which is part of the Visibly Vision Test…Lack of 510K clearance | Opternative Inc | 05/20/2019Open, Classified |
| Z-2442-2018 Class II | Health Harmony Mobile application software Product Usage: Care Innovations Health…It was discovered that in certain situations, including partial sessions and when taking adhoc measurements… | Intel-GE Care Innovations LLC | 12/06/2017Terminated |
| Z-1106-2017 Class II | Philips Cisco 3850 layer 3 switch, 865339 model WS-C3850-12S-E in use with IntelliVue…May experience a loss of centralized monitoring. | Philips Electronics North America Corporation | 12/27/2016Terminated |
| Z-0768-2017 Class II | MicroScan LabPro Data Management System. Intended to manage both microbial…Beckman Coulter has received and confirmed reports of an intermittent and unexpected behavior when loading… | Beckman Coulter Inc. | 10/25/2016Terminated |
| Z-1498-2017 Class II | Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge…System locks up which may result in potential patient injury or delay in diagnosis or treatment. | Merge Healthcare, Inc. | 04/04/2016Terminated |
| Z-1501-2016 Class II | CareLink iPro2 Reports, Model No. MMT-7340 is software intended to retrospectively…Medtronic MiniMed is recalling 19 CareLink iPro Therapy Management reports because the CareLink iPro reports… | Medtronic MiniMed Inc. | 02/19/2016Terminated |
| Z-1269-2016 Class II | MicroScan LabPro Information Manager System, Software Versions 1.0 to 4.41 Catalog No.…Beckman Coulter is recalling the MicroScan LabPro Information Manager System because the software… | Beckman Coulter Inc. | 02/11/2016Terminated |
| Z-0664-2017 Class II | Merge FlexConnect software, a component of Merge LIS. Merge FlexConnect is middleware…Communication protocols interfacing with the affected software version with some select instruments were not… | Merge Healthcare, Inc. | 01/30/2016Terminated |
| Z-2809-2015 Class II | MicroScan LabPro Information Manager System, Version 1.0 to Version 4.11, Catalog No.…The software incorrectly allows the operator to manually edit the carbohydrate substrates when manually… | Beckman Coulter Inc. | 07/17/2015Terminated |
| Z-0856-2015 Class II | Lite DM (Lite Data Manager) Software Version(s): Versions 2.0.0.19 and lower Product…HORIBA Medical is informing all HORIBA Medical Lite DM customers using software version 2.0.0.19 and lower… | Horiba Instruments Inc | 11/19/2014Terminated |
| Z-0993-2015 Class II | TEGRIS System manufactured by MAQUET GMBH in Germany The Maquet Tegris OR Integration…The wrong movement results on the MAGNUS OR table. The button commands on the TEGRIS touchscreen for Lower… | Maquet Medical Systems USA | 08/21/2014Terminated |
| Z-1646-2014 Class II | Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50 XIRIS is a…When using XIRIS Rio version (8.1.50.0) in conjuncture with iSite PACS a synchronization error can occur and… | Philips Healthcare Informatics, Inc. | 05/05/2014Terminated |
| Z-2275-2013 Class II | TEGRIS system Four labels of the Tegris System include: Emergency button (1703.72)…MAQUET has identified a potential issue that might occur because of the lack of an emergency stop button on… | Maquet Cardiovascular Us Sales, Llc | 08/19/2013Terminated |
| Z-1365-2013 Class II | MEDITECH Bi-Directional interactive Communication Analyzer Interface; Integrates with…Incorrect transmission of laboratory results. | Medical Information Technology, Inc. | 05/07/2013Terminated |
| Z-1942-2012 Class II | Philips Xcelera Connect, Software R2.1 L 1 SP2, an interface engine for data exchange.…Xcelera Connect R2.1 L 1 SP2 , incomplete information arriving from unformatted reports interface | Philips Healthcare Inc. | 06/14/2012Terminated |
| Z-0737-2012 | NicVue Software version 2.9.2 and 3.0.1. Medical Device Data System (MDDS) Intended use:…Under certain work flow processes, when selecting a new patient name in NicVue, the associated exams list… | CareFusion 209 Inc. | 12/16/2011Terminated |