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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…

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.…

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…

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

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

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…

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…

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

Baxter Corporation has received one complaint of a customer getting self-righting luer lock tip caps, yellow (product code h938690025) mislabeled as self-righting luer slip tip caps, yellow (product code h93866100). Recall start date: Feb 28, 2022

Due to the higher observed occurrence of esophageal perforations compared to the rate reported in literature, a product advisory is recommended to make users aware of the events and to reiterate and supplement the warnings and directions related to…

This is a performance update to system software VA10F and provides improvements of customer workflow and stability as well as remote update handling (RUH) functionality and cybersecurity updates. Recall start date: Mar 8, 2022