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Medical device and health technology recalls from FDA. Includes diagnostic equipment, implants, monitors, and therapeutic devices.
During an FDA audit, it was discovered that the product was not properly registered with FDA.
During an FDA audit, it was discovered that the product was not properly registered with FDA.
There has been an increased trend in reports of catheters failing to deflate during use, which may ultimately lead to tip separation.
The analyzer system may have an electrostatic discharge and sparking of the power supply provided with the analyzers resulting in the power supply becoming non-functional.
Space between the device and the packaging permits excessive movement which could potentially lead to the displacement of the anchors tip protector allowing the tip of the anchor to create a sterile breach.
RaySert PLUS RSP01 LOT K030 labeled with an expiry of 2024-01 contained an inner tray that was labeled with an expiry of 2015. In addition to having an expiry of 2015 the LOT number on the inner tray is identified as V001.
A "Remove USB Device 2" false alarm may be displayed when no USB device or a non-powered USB device is connected to the USB port on the rear of the machine
A "Remove USB Device 2" false alarm may be displayed when no USB device or a non-powered USB device is connected to the USB port on the rear of the machine
There is a potential for the occurrence of false positive OXSF results for some Staphylococcus aureus strains in conjunction with the VITEK 2 AST-P652 test card (ref. 421857, lot 8021232403). .
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
Through internal investigation is has been determined that an incorrect component was used within the power supply. The incorrect component may cause a short circuit within the power supply resulting in a delay in treatment. The delay could result in a range of risk from cyanosis and low blood pressure to cardiac arrhythmias and severe impairment of cardiac function.
The UDI on the device label indicates incorrect manufacturer.
Solder connection failure on Power Management printed circuit board assembly of ventilators may cause 1) Blower to lose power, spool down, and trigger visual and audible High Priority Check Vent alarm indicating a need for alternative ventilation, or 2) Intermittent connection may disrupt expected operation and trigger unexpected shutdown without alarm. Failures may lead to hypercarbia/hypoxemia
Potential for the weld to fail at the pivot point of the monitor bracket. This weld failure could cause the display interface and bracket to fall from its mounted location, resulting in injury.
Due to physical limitations of the treatment machine, the maximum field opening for Siemens Virtual Wedge fields recommended by the LINAC vendor will be more restricted in the wedged direction than the maximum field opening without a wedge. Delivering a larger field opening with a virtual wedge will not result in a wedged field shape over the entire field. Instead, a high dose plateau region will be the result at the toe side of the field beyond the recommended field size.
Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.