Medical device recalls

Medline has identified the presence of particulate within the fluid path of the Manifolds.

Medline has identified the presence of particulate within the fluid path of the Manifolds.

Medline has identified the presence of particulate within the fluid path of the Manifolds.

Medline has identified the presence of particulate within the fluid path of the Manifolds.

Medline has identified the presence of particulate within the fluid path of the Manifolds.

Due to broken connector which may result in a temporary interruption of prescribed cold therapy.

Due to broken connector which may result in a temporary interruption of prescribed cold therapy.

Due to broken connector which may result in a temporary interruption of prescribed cold therapy.

Due to broken connector which may result in a temporary interruption of prescribed cold therapy.

Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.

Affected kits contain Medline Namic RA Syringes, which are recalled by their manufacturer due to risk of syringe rotating adapter unwinding during use, which may result in a loose connection or full disconnection between syringe and manifold. If unwinding occurs, there is a potential for biohazard exposure, blood loss, infection. or air embolism.

Potential for mislabeled syringe produced by the i.v.STATION device.

Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the current scan position after pressing Go. 2. Potential where the message of Previous Surview Exists Select Previous Surview? <Yes> or <No> should display but does not appear. 3. After performing Surview and planning the Brain Helical acquisition by setting Brain Area DoseRight Index to increase the dose, there is the potential that the Define Head Area option in the context menu is grayed out.

On lot of Sterile Circumcision Kits was distributed without the required sterilization process and is therefore not sterile.

The potential for repeated frames during HF-OCT pullback when using the Gentuity HF-OCT Console (software version 21.11 to 23.3.13) with the Vis-Rx and Vis-Rx Prime catheters. This correction is intended to ensure that users are fully informed of how to recognize, avoid, and mitigate this condition to maintain accurate longitudinal (length) measurements during OCT imaging.

Increased difficulty in installing the centrifuge bowl onto the centrifuge bowl holder. Improper installation may cause the centrifuge bowl to dislodge, resulting in a broken bowl during the prime cycle or treatment phase, leading to a delay in patient treatment and blood loss.

Due to a quality issue regarding the presence of burr on the finished cervical plate product.

Increased rate of out-of-specification endotoxin results.

Increased rate of out-of-specification endotoxin results.

Increased rate of out-of-specification endotoxin results.

Increased rate of out-of-specification endotoxin results.

Increased rate of out-of-specification endotoxin results.

Devices which did not meet internal quality specifications were inadvertently distributed.

During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. The variation of brightness is a result of a constant unregulated medium dose and the angular change of patient diameter caused by rotational acquisition. This may result in unintentional low-dose radiation exposure to a patient.

Due to increased in complaints their is the potential for endoscopic clipping device to malfunction.

An internal component of the actuators in a certain production batch may not meet the required mechanical strength. This could result, in the worst case scenario, in a sudden loss of the actuator's ability to hold the load, leading to rapid and uncontrolled downward movement of the lifting arm.

The CORE Workstation may display an incorrect "Planning Date " when viewing cases on the "Start Case" menu screen.

it was found that in versions 1.3.7, 1.4.2, and 1.4.3, the Lock Screen and Limited Access Passcode Screen on the iLet graphical user interface (GUI) include certain icons displayed in the status bar that are active, thereby allowing the user to bypass those screens when those icons on the status bar are pressed, allowing unauthorized access while the device is in Limited Access Mode. A Health Risk associated with Limited access mode includes severe hypoglycemia due to unauthorized access to the iLet if someone were to make unauthorized meal announcements or stopped insulin delivery.

Products may report incorrect AST results during quality control. Health consequences may include delayed response or the need to change to another antifungal agent if laboratory ignores Quality Control test result.

Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (Interventional Tool). Philips has determined that the MAFA ratio does not provide reliable prognostic information regarding aneurysm occlusion following Flow Diverter Stent treatment, however despite being stated in the IUF, it is being relied on for making clinical decisions.