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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…

Baxter Corporation is issuing an urgent medical device recall for all non-expired lots of Self-Righting Luer Slip And Luer Lock Tip Caps listed due to the potential of the packaging seal not maintaining a sterile barrier for the tip caps. Recall start…

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…

A software defect is present where in the case that the customer is running on smart last cycle, and a procedure is aborted or has an unrecoverable interruption, the red blood cell loss estimation flag may not be accurate, and should not be used as the…

Distance and area measurements can display inaccurate measurement values that are overestimated (measurement size is larger than true size) when a study is launched in global stack viewport on centricity universal viewer and universal viewer. …

The field action FMI 32067/ and customer communication, plus enhanced panel design were launched in March 2019 and July 2020, respectively. However, GE Healthcare recently received one complaint of a patient fall related to the bedside panels not being…

Some cartons of the lot of Vitek 2 Ast cards have been identified as impacted by a card and/or card label mix issue during production at the manufacturing site.  The card and label of the card are incorrect and are from another Vitek 2 ID or AST…

Ortho Clinical Diagnostics (Ortho) became aware of an anomaly that affects Vitros Xt 3400 and Vitros Xt 7600 systems. These systems utilize a digital imaging reflectometer and led light source to generate Vitros microslide assay results. Ortho's on-going…

A system error and termination of program may occur. This may occur when a patient was previously programmed with an A610 dbs clinician programmer application v.2.0.x or later, and later the same device is interrogated with a clinical programmer tablet…

There may be a burr present on the co-packed Osseoshaper 1 around the waist of the device. There is a risk that the burr can come loose from the device. Recall start date: July 26, 2022

Incorrect expiration date past shelf life and product testing: during the manufacturing process of the Phaseal Y-Site Connector C80, the quality inspector observed that the expiration date of the product was not correctly calculated. Recall start date…

Abbott has identified that a subset of Assurity and/or Endurity pacemaker(s) are impacted by a manufacturing issue.  As background, the issue in this recall is connected to a manufacturing laser roughening process, unique to a single assembly site…

The affected products with SW version 1.3 and lower may have potential cybersecurity vulnerabilities with unauthorized physical access to the USB data interfaces of the device. Recall start date: June 7, 2022

UPDATE (2022-07-27): Update on Philips Respironics recall of several models of CPAP and BiLevel PAP machines and mechanical ventilators Health Canada is providing an update on the progress of Philips Respironics’ (Philips) recall of several models of…

Beckman Coulter has discovered software anomalies in Kaluza C that may lead to the generation of erroneous results. Recall start date: June 28, 2021