All Recalls

Potential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains.

In the Azurion system, the user can add a new study to a patient by selecting the option "Add Study". The Add Study dialogue box is then displayed where the Patient Type is selected to perform the study. Due to a software defect, when the study is initiated by pressing Start Procedure , the Patient Type changes inadvertently to a Patient Type different than the one selected as shown in the Table below. Patient type is one of the factors involved in the dose control process. The incorrect patient type changes the technique factors to be used by the system without notification to the user.

In 2018, Philips Respironics added foam replacement to the preventive maintenance schedule for these devices after discovering the polyester-based polyurethane (PE-PUR) foam may degrade into particles. This 2018 correction has been superseded by the device removal and rework described in Philips Respironics 2021 recall action for the same devices.

Instructions for Use (IFUs) updated to include use of a headband is now recommended for all patients and instructions for the application of the headband. Additionally, IFU updated to include warnings for risk of condensation build up depending on environmental conditions with instructions.

When two or more high-powered magnets are swallowed, either intentionally by younger children or accidentally by older children, the ingested magnets can attract to each other, or to another metal object, and become lodged in the digestive system. This can result in perforations, twisting and/or blockage of the intestines, infection, blood poisoning and death.

The ATVs fail to comply with the requirements of the federal mandatory ATV safety standard. The B125 ATVs exceed the maximum speed limitations for vehicles intended for children aged 10 and older. For the Madix 110, the parking brakes do not prevent the movement of the vehicle. In addition, the handlebars on both ATVs pose a laceration hazard should the rider's body or head impact the handlebars at a high rate of speed such as in a crash. ATVs that fail to meet the mandatory safety requirements pose a risk of serious injury or death.

During manufacturing pieces of hard clear plastic was found. Upon investigation the source was identified as ice purchased from supplier.

During manufacturing pieces of hard clear plastic was found. Upon investigation the source was identified as ice purchased from supplier.

Dietary supplement may contain potential metal shavings greater than or equal to 7mm in length.

During manufacturing pieces of hard clear plastic was found. Upon investigation the source was identified as ice purchased from supplier.

Firm distributed Dried Salted Plum (Saladitos) that may contain high lead levels.

Foreign Material - Small Rocks

Undeclared almonds

During manufacturing pieces of hard clear plastic was found. Upon investigation the source was identified as ice purchased from supplier.

Firm distributed Dried Salted Plum (Saladitos) that may contain high lead levels.

Production Process not approved for acidified foods.

During manufacturing pieces of hard clear plastic was found. Upon investigation the source was identified as ice purchased from supplier.