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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…

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.…

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…

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

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…

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

Boston Scientific is conducting a removal of specific batches of rotawire drive and wireclip torquer after determining that a small number of pouches containing these products may have a weak seal, which could open during normal shipping and handling and…

The purpose of this recall is to inform the customer of a product recall for architect stat myoglobin calibrators, ln 2k43-01, lot number 166000. They have identified that this calibrator lot did not meet acceptance criteria during ongoing stability…

On February 28, 2022, the manufacturer discovered that the endotoxin concentration of the product in some samples has been measured above the limit. Recall start date: Mar 8, 2022

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…

Beckman Coulter has become aware of an increase in complaints generated for Irispec Ca failures for glucose on the ichemvelocity instrument. If a Qc run fails, the system will not allow the operator to run specimens. The Qc run should be repeated and be…