All Recalls

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

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

Potential for Fluid Leak inside a staining system that could cause an electrical short circuit of the General Purpose Input/ Output Board's J1 Connector that could result in smoke and fire.

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

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.

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

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

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

ODs of the standards too low(< 0.6 ODmax) may cause invalid runs, delayed patient results are possible

Sterility failure of the exterior of the syringe which may impact the device's ability to be laid on a sterile field.

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

Potential for a loose cylindrical pin on the Transport Guard that may result in the jamming of the locking mechanism causing the Transport Guard to not open or, if the locking pin is fully disengaged from the assembly, a full disassembly of the Transport Guard may occur, resulting in a delay of support if a product exchange is necessary.

Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released.

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

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

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

Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released.