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ICU Medical has identified the potential for a manufacturing defect within specific lots of Microclave clear sets, which may result in a visible gap between the Microclave clear connectors top and bottom housings. Inadequate connection between the…

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. …

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…

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

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…

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

Boston Scientific Corporation is initiating an advisory to inform customers that if limited supply of model 3300 latitude programmers exists locally, Boston Scientific recommends continued use of older model 3120 zoom programmers. Consequently, users may…

In December 2020, Boston Scientific committed to developing a software enhancement that detects and alerts Healthcare Professionals (HCPs) if an Emblem S-Icd exhibits hydrogen-induced accelerated battery depletion. This enhanced software allows…

Baxter is issuing an urgent medical device correction communication regarding the potential for leaking valves in the Exactamix 2400 valve sets. Baxter has observed an increase in complaints for leaking of ports 1 and 2 when in the closed position,…

Leica Biosystems recognized through post market surveillance 7 vulnerabilities affecting remote care, The remote access solution produced by Axeda, (collectively known as access:7). Exploiting these vulnerabilities, attackers with network access to a…

Cook Medical identified that samples from the affected device lots did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing. This failure was traced to material that is supplied to Cook Medical from an…

Medtronic is informing customers about an update to instruction for use which provides a validated manual deployment workaround method to help mitigate potential harms related to the low risk of partial stent deployment. Recall start date: July 14,…

Siemens Healthineers has received customer complaints for negative patient bias with the Dimension Vista Loci Ca15-3 assay. Siemens has confirmed the Dimension Vista Loci Ca15-3 lots show a negative bias with patient samples. The mean patient sample bias…

During post-market surveillance, we have found that the IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs. The information displayed directly in the software is correct. Recall…