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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…

This recall addresses an incorrect needle size concern in the kits. Some of the needles for product code 80-8139 and lot 163309 contained shorter sized needles instead of the labelled larger size (3.5 inch). Recall start date: July 14, 2022

The former packaging design of HLS set contains accessories packed in medical paper as opposed to the new introduced packaging design in Tyvek. Based on design verification tests it showed that medical paper is a weaker technical solution than Tyvek,…

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…

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,…

Maquet Cardiopulmonary Gmbh (MCP) has received customer complaints of damage to the primary packaging of the Hls Set Advanced. In all it was reported that the Tyvek cover was damaged. Investigation suggest that the Tyvek damage only occurs if the set…

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…

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…

On 03/17/2022, a Stryker spine operator packaging non-sterile Yukon Straight Rods from finished goods inventory discovered a Yukon Straight Rod 120 mm (cat#7601-540120, lot# pcmw) with orange and white discoloration on the surface of the device.…

This recall is regarding fluid leaks within the middle stainer module of the Ventana he 600 that likely resulted in electrical shorts at the plate heater connections that then escalated into fires. Recall start date: June 16, 2022

Internal stability testing was performed with the Pas Staining Kit where it was confirmed that the stability of 24 months could not be met. The expiration date of the product was reduced to 12 months after the manufacturing date. Recall start date:…