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One client reported that HL7 files transferred to an outbound results interface (specific to one client) would sometimes contain more than one patient identifier, which could lead to results being assigned to the wrong patient in a third party system…

For some insulin mentor feature users, there is an overlap in their time-intervals. this causes the system to provide an incorrect insulin recommendation to the user and could potentially result in a deviation from the value the user should be getting…

An end user site attempted to perform QC on a single test using multiple QC kits. The QC module was not designed to support testing of multiple QC kits for a single test, and it is required that all QC samples used to validate a test are contained in a…

A software update for carelink SmartSync™ device managers (SmartSync) will address a telemetry error that may occur with Medtronic Cobalt™ and Crome™ Implantable Cardioverter Defibrillators (ICDs), and Cardiac Resynchronization Therapy Defibrillators (…

Issue 1 - Indication of block movements function: When the operator activates the functions "block movements" or "block table movements" by pressing the block movements button on the pilot control module, there will be a dedicated message displayed on…

Shift of FMRI overlay and no direct possibility to correct the alignment contribute to an incorrect surgery planning when not detected: - The original error is not generated in the software but a manual error during the scan. - Incorrect anterior/…

During the transmission of the patient table position information, sporadic interference signals may occur due to an error within the patient table position encoder. This problem can be detected by the system and can result in a scan abort. Sporadic…

This update package provides the update VB40B_HF06 for Syngo.Via systems running on version VB40A or VB40B. This update solves several issues and introduces several improvements. Recall start date: Apr 18, 2022

This update package provides the update VB30B for Syngo.Via systems running on version VB30A and any patch level. Recall start date: Apr 14, 2022

Ortho Clinical Diagnostics received a complaint regarding an incorrectly displayed passing QC status for a test (see example in table below), without the site having processed the multiple QC kits configured for the test. Ortho confirmed that any test…

Following Shimadzu's investigation, it was noted that there is a potential issue with the system software that could cause: 1) The x-ray irradiation rate (pulse rate) of pulse fluoroscopy to be different then set value, 2) The beam hardening filter…

Bias flow selection for NO system usage is missing from the user interface of Fabian HFOi Ventilators following incorrect selection of device configuration during a software update. This is caused by human error and there is no defect in the device or…

The Reveal Linq Mobile Manager application (MSW002) versions 2.01, 2.02, 2.03.0, and 2.03.01. These versions of LMM have an updated insertion workflow that, if not followed properly, increases the likelihood the patient connector is removed from the…

Smiths Medical became aware of eight (8) issues-(identified below) that can potentially occur that may impact therapy delivery in specific Medfusion 3500 and 4000 syringe infusion pumps. 1. Primary Audible Alarm (PAA) 2. Unanticipated depleted battery…

During alarm conditions, the audible alarm may not sound and/or the omnidirectional led visual alarm may not illuminate as described in the operator's manual. Recall start date: Apr 1, 2022