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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

The Vial 1 assay may be out of specification in the affected lot(s).

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

Potential for injury if the MR system is incorrectly deinstalled. Recall start date: Mar 10, 2022

Potential for injury if the MR system is incorrectly deinstalled. Recall start date: Mar 10, 2022

Potential for injury if the Mr system is incorrectly deinstalled. Recall start date: Mar 10, 2022

UPDATED INFORMATION – May 6, 2022 Further to the communication below, issued on March 15, 2022, regarding the potential for the presence of particulate matter in vials of Sodium Acetate Injection, USP (DIN 02139529) from lot 6126554, Fresenius Kabi…

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…