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During global post market surveillance activities cases have been reported that the sampling pump 6873493 shows a changing characteristic with increasing operating time, which can lead to the deactivation of the gas measurement during operation. The…

Dräger has become aware of one case in which an obstructed Breathing System Filter Safestar 55 was used on a patient during anesthesia. The patient reportedly became hypoxic and had to be reanimated. If an obstructed filter is used on a patient,…

Reports of products having torn corrugated breathing tube.   - Should a tear be detected before use, a delay may be experienced while another product is located.   - Should a tear be detected during use, this may result in a leak and…

Carescape R860 ventilators, and Engström Carestation and Engström Pro ventilators with affected field replacement batteries - insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply…

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…

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

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.…

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…

Through investigation following a product compliant (November 11, 2021), Stryker has identified a software bug in the 1688 camera control unit (CCU) that can cause the image on the monitor to flip upside down (only) when used in conjunction with the 1688…

Reports from the field indicated that customers were experiencing problems with the Trivantage EMG tubes such as having difficulty passing the electrode check screen on the NIM mainframe immediately after intubating the patient, losing the connection…

Ventilation stops during clinical use, with waveforms and parameters frozen (not updated). a continuous audible/visual high priority alarm for technical failure 305 is generated. ventilation is suspended until unit is rebooted/replaced. Recall start…

Cardinal Health has initiated a medical device correction for specific production lots of nonabsorbent towels with adhesives manufactured between March 2021 and October 2021 due to varying levels of adhesion. Affected non-absorbent towels are supplied in…

Smith & Nephew, Inc., has initiated a field action to voluntarily remove three lots of the Acufex Access Advanced Positioning Kits due to the sterilization omission. The affected products were inadvertently shipped to the global distribution center…

This voluntary medical device correction is being taken following the investigation of six customer reports stating that a total of four ventilators became inoperable during use. One of these reports indicated that, following the ventilator becoming…