Medical device recalls

There is a potential for misquantitation high results for negative samples.

There is a potential for misquantitation high results of negative samples.

There is a potential for AED pads to experience gel separation from the foam/tin backing when peeled from the plastic liner. The gel may fold onto itself resulting in reduced surface area or gel on the pad, or it may separate almost completely leaving only a small amount of gel on the pad.

There is a potential for AED pads to experience gel separation from the foam/tin backing when peeled from the plastic liner. The gel may fold onto itself resulting in reduced surface area or gel on the pad, or it may separate almost completely leaving only a small amount of gel on the pad.

A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.

A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.

A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.

Samples, run on a GBS Assay, that have analyte concentrations that are at or near the limit of detection may produce false negative results.

IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse events

IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse events

Due to a software defect, the Philips StentBoost Live R2.0 might not process X-ray images of the current run and instead show an image processed in a previous run. The image shown could be from the same patient or from a different patient.

Cybersecurity Improvement Action-not equipped against potential cyber security threats

Cybersecurity Improvement Action-not equipped against potential cyber security threats

It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1020.32 in some specific case of fluoroscopic mode due to inadequate adjusting criteria in installation.

It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1020.32 in some specific case of fluoroscopic mode due to inadequate adjusting criteria in installation.

It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1020.32 in some specific case of fluoroscopic mode due to inadequate adjusting criteria in installation.

The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.

The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.

The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.

The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.

The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.

Distribution of Defibrillators that are not approved or cleared for distribution US Market.

There is potential for the images to be flipped left to right.

There is potential for the images to be flipped left to right.

There is potential for the images to be flipped left to right.

There is potential for the images to be flipped left to right.

Due to failure of microbial testing for total aerobic microbial count (TAMC).

The accumulated dose is incorrectly displayed in certain situations. There are two situations that will result in the SmartStep displayed dose being inaccurately high.

The accumulated dose is incorrectly displayed in certain situations. There are two situations that will result in the SmartStep displayed dose being inaccurately high.

Due to an incorrect configuration setting in the EPX database of StentBoost Live, acquisition does not stop automatically as it should. When the user selects the StentBoost Live protocol on the Philips Azurion system, the following on-screen message is displayed to the user in the Philips StentBoost Live application: "Press the cine pedal until the acquisition stops". However, due to the incorrect configuration of the EPX database, the acquisition does not stop after 40 images, but instead it continues as long as the pedal is pressed.