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seca 452

seca GmbH & Co. KG · Model 452 · UDI-DI 04012030019644

OUG

510(k) clearances

2,991

Adverse events (10 deaths)

Recalls

311

Facilities

Description

With the Interface Module seca 452 seca scales can be refitted with minimum expense and effort to make them fully integrated via seca software. The module can be installed in a easy-to-assemble holder directly on the product and then configured via the central server. LEDs indicate readiness for use, give the user feedback on the scanned patient barcode and confirm successful transmission of measurements to the electronic medical record system.

Recalls

Date	Firm	Reason
2023-03-08	Radiometer Medical ApS	Due to potential software issue that may result in patient mix-up information.
2023-02-06	Biomerieux Inc	For users with MYLA V4.8.X / V4.9 that use VITEK MS to identify organisms as part of their workflow, AST filter rules that have been activated are not always being applied to AST r
2021-09-02	BioMerieux SA	Under certain conditions, there is a risk for a false negative result.
2020-09-22	Pentax of America Inc	There is an intermittent software issue that could affect the systems, in which an exam video for one patient (Patient A) might be copied to another patient (Patient B). This does
2020-09-22	Pentax of America Inc	There is an intermittent software issue that could affect the systems, in which an exam video for one patient (Patient A) might be copied to another patient (Patient B). This does
2020-01-17	Beckman Coulter Inc.	A security-only update was released via remote diagnostics on January 14, 2020 to customers with Windows 7 operation system. Shortly after the releases some customers reported that
2019-09-25	ENDOTRONIX	The firm have received reports of patients myCordella Hubs fully powering themselves down without interaction from the patient or Endotronix.
2019-08-08	Radiometer Medical ApS	The firm has become aware that there is a potential problem relating to the blood gas and immunoassay analyzer Systems that may result in patient mix-up when connected to some thir
2019-05-20	Opternative Inc	Lack of 510K clearance
2017-12-06	Intel-GE Care Innovations LLC	It was discovered that in certain situations, including partial sessions and when taking adhoc measurements, the patient data was not synchronizing in a timely manner with the back

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.