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Baxter Corporation is issuing a correction for the Prismax. If the operator initiates therapy by entering a value other than the default value for the patient gain/loss limit or the return pressure drop limit and uses the same patient function, the…

Abbott is notifying physicians of a programmer software anomaly that may be encountered in a very specific circumstance when executing a pacing capture decrement test in-clinic on a gallant, neutrino NXT, or entrant device using a merlin patient care…

All V60/V60 plus and V680 units have been identified to have potential issue that could affect the main electrical circuit ("35V rail") powering the ventilator and alarm. In some cases, this issue may result in either one of the following scenarios: 1.…

Siemens Healthcare Diagnostics Inc. has confirmed the potential for falsely elevated hcg results due to sample carryover. This can be observed when a sample is assayed for HCG immediately after an undiluted sample with a HCG value of GT;5000 MIU/mL. This…

Devices from these lots may exhibit leaks and/or a loose connection at the rotating luer assembly or stopcock connection, which could lead to air ingress under vacuum. Analysis indicates an estimated rate of occurrence of air ingress associated with the…

The manufacturer, a third-party supplier (Mani, Inc.), discontinued production of the Mani™ Diamond Tomita-Saw™ product and subsequently terminated the medical device license for this device. Recall start date: Nov 24, 2021

HS1/onsite/home AED pads (pn: m5071a, m5072a) have been observed to experience gel separation from the foam/tin backing when peeled from the yellow plastic liner. The gel may fold onto itself resulting in reduced surface area of gel on the pad, or it may…

There is a potential issue with Artis systems in Syngo application software version VE20. After CT image data from toshiba is loaded, unintended image mirroring can occur along the horizontal and vertical image axes. Recall start date: Mar 4, 2022

Muse™ NX R1 systems with web edit option - edits can be lost after test is confirmed. Recall start date: Mar 9, 2022

Stryker has discovered (via complaint trending initiated February 2022) that any one of the following product markings on the Triathlon® primary and Tritanium tibial baseplates listed above may be incorrect: catalog number, lot number, and/or size (2…

Siemens Healthcare Diagnostics Inc. has confirmed customer observations of falsely elevated results when using plasma specimens across the entire analytical measuring range (AMR) with the Atellica IM enhanced estradiol (EE2) assay. Results demonstrate…

Beckman Coulter has identified that order number(s) 41231574 and 41231557 for the shipment of Iq200 Control/Focus Set (part number 800-3104, lot# 146-21) and Iq200 Calibrator (part number 800-3103, lot# 146-21) were inadvertently frozen prior to shipment…

FA-000604, which was distributed in August 2021, notified customers of possible intra-assay carryover. The letter communicated that clinically significant carryover into a reagent pack (into-pack) can occur if an Access Hstni test is performed after a…

The abovementioned ventilators use specially hardened operating system. Components of the imbedded operating systems can no longer be updated, and any potential vulnerabilities cannot be addressed. Therefore, they are not prepared against potential cyber…

The device was incorrectly classified by manufacturer as a class I medical device and is in fact a class II medical device, which requires a medical device licence. Health Canada provided guidance on classification on December 24, 2021. Recall start…