Other Medical Devices

Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tampering, or remote code execution via remote login to the Flow Anesthesia System, any of which could lead to a hazardous situation.

X-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermittently not emitted per 21CFR 1020.31(j) requirements.

Magnetic materials were used for the wheels of trolley. Wheels with magnetic material might be attracted to MRI systems if the wheels are in the magnetic field.

Randox Laboratories have released an update to the Carryover Avoidance Technical Bulletin to detail that Copper, should not be run directly after Total Protein, on the RX series instruments testing order. If copper assay is run after total protein it could lead to falsely elevated copper results.

A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment.

Detector may unexpectedly fall due to a component failure. If the detector is positioned below center of gantry, there is a potential for abrasion, contusion, laceration, and/or fracture to the patient's lower limbs, as well as an interruption to normal system operation. If detector is positioned above center of gantry, there may be an interruption to normal system operation.

Magnetic materials were used for the wheels of trolley. Wheels with magnetic material might be attracted to MRI systems if the wheels are in the magnetic field.

Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tampering, or remote code execution via remote login to the Flow Anesthesia System, any of which could lead to a hazardous situation.

Detector may unexpectedly fall due to a component failure. If the detector is positioned below center of gantry, there is a potential for abrasion, contusion, laceration, and/or fracture to the patient's lower limbs, as well as an interruption to normal system operation. If detector is positioned above center of gantry, there may be an interruption to normal system operation.

The Bubble Sensor optional accessory to the CARDIOHELP-i extracorporeal life support system includes an incorrect UDI Device Identifier (DI) provided with the label attached to the device.

Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tampering, or remote code execution via remote login to the Flow Anesthesia System, any of which could lead to a hazardous situation.

Latex elastic bands were labeled as non-latex elastic bands, an allergic rx can occur due to patient latex allergy

Barco became aware of a problem with I2C cables in the manufacturing process of a limited batch of MDSC-85xx NXF products. The functionality of the built-in MNA decoder is blocked.

Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tampering, or remote code execution via remote login to the Flow Anesthesia System, any of which could lead to a hazardous situation.

Affected product may not perform as expected; the amalgam powder may not triturate correctly and the physical properties (i.e. strength, compression, working time, etc.) will be adversely affected.

There are potential performance issues found in the DxI 9000 Access Immunoassay Analyzer, including: 1) Access Ultrasensitive Insulin users who configure SI units (pmol/L) applies an incorrect conversion factor; 2) System provides numerical results that are below the lowest reportable result if laboratory chooses to report assay results in units of measurement other than the defined default units; 3) A result of 0 incorrectly reported when the system utilizes an expression that utilizes non-numerical symbols (e.g., > or <) to derive a calculated test as part of result reporting; 4) Reserve volume is enabled and the assay LIS code is not the same as the assay Test ID. These issues could potentially lead to erroneous results or delay reporting results for multiple analytes.

Dual-articulating head rest may not stay in place or may fail to lock into position during a patient procedure which could result in an injury to the patient or a procedural delay.

The device has a grip detail (right angle latch) out of specification causing the bur to not adequately latch in the handpiece.

Some sensors may have a glucose oxidase (GOX) layer thickness outside of specification (5.5 to 9.2 ¿m). A non-conforming GOX layer thickness could impact sensor function (sensor glucose value) or loss of sensor function due to the sensor layer being too thin. The potential impact resulting from this issue ranges from user inconvenience to over/under delivery of insulin, possibly resulting in hyperglycemia or hypoglycemia, if the sensor glucose values are affected. The issue was identified by the manufacturing team during the execution of Filmetrics Measurement for a Guardian Sensor lot.

The lower layer component of a sperm separation Kit does not match the certificate of analysis. The kit should contain lower layer (Lot: 0000020686, Shelf Life: 31 December 2024) but incorrectly may contain lower layer (Lot number 9925811106, Shelf Life: 30 November 2023).