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Software versions prior to 2.04 show a waveform while in suspend processing, while software version 2.04 and above do not show a waveform. Both software versions show an error message stating "ECG processing suspended" in the waveform zone, "?" in the…

Affected lot(s) may contain the presence of Burkholderia contamination. 

Baxter Corporation is issuing an urgent medical device correction for the Voalte Patient Safety, previously branded as Navicare Patient Safety, software versions 3.9.200 through 4.0.401. Baxter identified a potential risk where the "safety" monitoring…

Philips has become aware of a software login issue associated with specific models of Mobilediagnost wDR systems running on Windows 10 operating system preventing use of the system. This issue occurred because the software certificate protecting the…

Ortho™ Sera Papain is used to enhance reactivity of Ortho™ Sera red blood cell antigen typing reagents and red blood cells when used in in-vitro immunohematology assays. Through a customer complaint investigation, the reactivity of Ortho™ Sera Papain of…

Affected lots are incorrectly labelled for use in the subpopulation that is less than 4 years of age.

Biomerieux identified a manufacturing event that may contribute to elevated rates of false negative results while using the Biofire RP2.1 panel. Biomerieux has not received any false negative complaints from the field but, out of an abundance of caution…

Baxter Corporation is issuing an urgent medical device recall for the Allen Advance Chest Support to inform customers of the potential for the device to crack where the chest base and prone supports attach to the carbon fiber operating room (or) table…

Stryker has determined that size 11 (11mm) height peek Ogival Interbody Cage (OIC) was incorrectly laser marked as having a size 10 (10mm) height. Recall start date: May 19, 2023

Affected lot may contain heavy metal (arsenic) above the acceptable limit.

During the course of global market surveillance activities, the manufacturer has become aware of cases where Oxylog 3000 Plus emergency and transport ventilators have stopped ventilation due to empty batteries despite being reconnected to the mains power…

Currently, the Hemospray instructions for use states "Potential complications: when spraying in the retroflexed position, Hemospray powder may adhere to the outside of the endoscope. This may result in difficulty repositioning / removing the endoscope,…

The dextrose content is out of specification in the affected lot.

A concern with the software network binding of the Universal Copy  Service (UCS), an ILMN proprietary software component present on ILMN instruments. The concern expressed was that the software process running as a tcp service was found to bind to…

Presence of Sorafenib in affected lots.