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It has come to Xvivo knowledge that the sterile barrier (welded polybag) show defects in the weld for a number of batches of the Xvivo Organ Chamber. Defect was categorized as unsealed sections of the weld (compromised sterile barrier). To reinforce the…

This update package provides the update VB40B_HF06 for Syngo.Via systems running on version VB40A or VB40B. This update solves several issues and introduces several improvements. Recall start date: Apr 18, 2022

Radiometer has been performing integrity testing of the Pico50 arterial blood sampler packaging material. Integrity studies included sterility testing to show that the integrity of the sterile barrier system is intact. In the 24 month real time study, 1…

This update package provides the update VB30B for Syngo.Via systems running on version VB30A and any patch level. Recall start date: Apr 14, 2022

The proximal marker on devices from these lots may separate from the device. A dislodged marker may require additional intervention, including unplanned additional coronary intervention, or surgery. To date Abbott has received 5 complaints related to…

Steris has identified that in the remote occurrence in which the electrical contactor component present in the drying chamber of the Reliance Synergy Washer/Disinfector malfunctions, the heating elements in the drying chamber could overheat, eventually…

Cardinal Health is initiating an urgent medical device correction to update the clinician and patient user manuals for the Negative Pressure Wound Therapy Sved Device to add pertinent information related to periodic preventative maintenance for this…

The Universal Plus™ Laparoscopic Electrodes devices are sold as single use, sterile devices. Conmed received reports that the tip of the electrode could detach during use. Recall start date: Apr 19, 2022

The battery wiring harness on the effected TDX SP2 narrow base wheelchairs may become disconnected during shipment from the factory or during wheelchair use traversing large obstacles or after a jolt or impact to the wheelchair. The disconnection of the…

Avanos medical is conducting a voluntary field correction for the Cortrak* 2 Enteral Access System (Eas) because modifications to the labeling of the device have been initiated. Reports of injuries and patient deaths related to misplacement of…

Ortho Clinical Diagnostics received a complaint regarding an incorrectly displayed passing QC status for a test (see example in table below), without the site having processed the multiple QC kits configured for the test. Ortho confirmed that any test…

Following Shimadzu's investigation, it was noted that there is a potential issue with the system software that could cause: 1) The x-ray irradiation rate (pulse rate) of pulse fluoroscopy to be different then set value, 2) The beam hardening filter…

Bias flow selection for NO system usage is missing from the user interface of Fabian HFOi Ventilators following incorrect selection of device configuration during a software update. This is caused by human error and there is no defect in the device or…

During alarm conditions, the audible alarm may not sound and/or the omnidirectional led visual alarm may not illuminate as described in the operator's manual. Recall start date: Apr 1, 2022

Siemens Healthcare will be distributing new operator's manuals to affected customers which are needed for the upcoming software upgrade to VF11. 5 cautions were added to the manual. Caution 1 (added two sentences to already existing caution): cause:…