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MINILIM

HOPI MEDICAL · Model MINILIM · UDI-DI 03770034761013

OUG

510(k) clearances

2,982

Adverse events (10 deaths)

Recalls

316

Facilities

Description

An electrically powered telemedicine cart designed to enable real-time, interactive transmission of audio and visual data between two or more locations. The MINILIM teleconsultation cart allows healthcare professionals to communicate remotely with other professionals or directly with patients. The system includes a built-in screen, camera, microphone, and speaker, mounted in a cart. It is designed to accommodate and interconnect medical devices and optional accessories (such as a digital stethoscope, otoscope, ECG, or other examination devices) to facilitate remote clinical assessments.

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.