Recalls for Medical Device Data System

Due to potential software issue that may result in patient mix-up information.

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 results when sending the results to the clinician.

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 not occur at the time the user performs and initially reviews an exam; it is not evident until a follow-up review occurs.

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 not occur at the time the user performs and initially reviews an exam; it is not evident until a follow-up review occurs.

Beckman Coulter has received and confirmed reports of an intermittent and unexpected behavior when loading new panels into a WalkAway instrument using LabPro Data Management System version 4.42. The issue could cause workflow interruption with a potential of delaying reporting results due to the inability to begin processing new panels.

The software incorrectly allows the operator to manually edit the carbohydrate substrates when manually reading dried overnight gram negative panels with an ID Hold status.

The wrong movement results on the MAGNUS OR table. The button commands on the TEGRIS touchscreen for Lower Leg Up and Upper Leg Down are switched in the software for the integration with the MAGNUS operating table system.

HORIBA Medical is informing all HORIBA Medical Lite DM customers using software version 2.0.0.19 and lower of a software bug related to the potential for results received being applied to the wrong order in the Lite DM Worklist. This bug has not been seen in software versions above V2.0.0.19 IMPACT: Potential for results received being applied to the wrong order in the Lite DM Worklist. The is

When using XIRIS Rio version (8.1.50.0) in conjuncture with iSite PACS a synchronization error can occur and if not noticed, information for the incorrect patient may be displayed

MAQUET has identified a potential issue that might occur because of the lack of an emergency stop button on a secondary touch screen display on the TEGRIS System.

Incorrect transmission of laboratory results.

Xcelera Connect R2.1 L 1 SP2 , incomplete information arriving from unformatted reports interface

Under certain work flow processes, when selecting a new patient name in NicVue, the associated exams list may not properly refresh, and may continue to display the previous patient's exams.

Under certain conditions, there is a risk for a false negative result.

The firm have received reports of patients myCordella Hubs fully powering themselves down without interaction from the patient or Endotronix.

Communication protocols interfacing with the affected software version with some select instruments were not properly handled, preventing data captured by these instructions to be processed by the rest of the LIS software.

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 third-party devices. The error may lead to serious adverse health consequences for the patient caused by patient data mix-up.

May experience a loss of centralized monitoring.

Beckman Coulter is recalling the MicroScan LabPro Information Manager System because the software incorrectly allows the operator to manually edit the carbohydrate substrates when manually reading dried overnight gram negative panels with an ID Hold status.

System locks up which may result in potential patient injury or delay in diagnosis or treatment.

Medtronic MiniMed is recalling 19 CareLink iPro Therapy Management reports because the CareLink iPro reports were created using the Pacific Standard Time zone as the time reference, although the patients and their sensor data were subject to the Central Standard Time zone. The CareLink iPro2 Professional CGM (continuous glucose monitor) data uploading error that resulted in an inaccurate time zone being applied to 19 CareLink iPro reports.

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 Data Management System computers would not restart. If the computer is unable to restart, then the system cannot download data generated from MicroScan instruments or manually entered microbiology test results, resulting in a potential of delayed results.

Lack of 510K clearance

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 backend database, resulting in the patient's clinician not getting patient data tor one or two days.