All Recalls

Fluctuations may be more likely to occur if the total flow through the device sensor (used by the device to determine flow) is less than the minimum device requirement of 0.5 LPM. In addition, dose fluctuations have been observed when Bunnel LifePulse HFJV system or conventional ventilators have the following device settings: low service pressures generally less than 3.0 PSI, a pressure difference greater than 5.0cm H2O; or at breath per minute rates of 300 (5 Hz).

Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.

It has been found that when SPOT Fluoro is first turned on, the default ROI is selected and the collimator blades move to the boundary of the ROI, and the static image is overlayed around the ROI, covering the collimated area. If the customer changes the ROI, the collimator blades and static images are adjusted accordingly. However, when the acquisition program is changed, the collimator returns to the default ROI position which may be larger than the specified one, leaving the X-ray area partially covered by the static image. This is a software problem with the SPOT Fluoro program and will not occur if the function is not used.

Potential for the lid of the catheter connector to be in the incorrect position.

Firm has identified a security vulnerability in AW Server products. If exploited, a malicious actor could compromise the confidentiality, integrity, and availability of patient data.

Potential for the lid of the catheter connector to be in the incorrect position.

Potential for the lid of the catheter connector to be in the incorrect position.

Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC).

Potential for the lid of the catheter connector to be in the incorrect position.

Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.

The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces.

Production assembly error resulting in the potential for reversed articulation, where moving the lever forward caused the probe tip to anteflex rather than retroflex, and vice versa.

Potential for the lid of the catheter connector to be in the incorrect position.

Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.

The FlexLab X System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples. This function has not been evaluated for safety and effectiveness by the FDA, so its use may cause an increase in erroneous results or a delay in patient results.

Potential for the lid of the catheter connector to be in the incorrect position.

Potential for the lid of the catheter connector to be in the incorrect position.

Potential for the lid of the catheter connector to be in the incorrect position.

Potential for the lid of the catheter connector to be in the incorrect position.

The FlexLab System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples. This function has not been evaluated for safety and effectiveness by the FDA, so its use may cause an increase in erroneous results or a delay in patient results.