NuOss Collagen (dental) was packaged with a Collatene Fibrillar Collagen(for oral wounds) rather than NuOss Collagen Block, may result in suboptimal bone repair
Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical intervention, and/or extension of surgery to find another part.
Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical intervention, and/or extension of surgery to find another part.
Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical intervention, and/or extension of surgery to find another part.
Incorrect extended expiration dates identified on the outer box label only, if product is used past the correct expiration date there is a potential for pain, infection, or adverse tissue reaction to occur
Units not properly inspected prior to release to the market, may not function as indicated in the product labeling, resulting in syringe detection and infusion accuracy that can result in delays in therapy, overinfusion, or underinfusion.
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 This 2018 correction has been superseded by the device removal and rework described in Philips Respironics 2021 recall action for the same devices.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.
Federal regulations require bicycles with seat heights that measure at or below 25 inches to be equipped with foot brakes. These bicycles are equipped only with hand brakes and can pose a crash hazard or a risk of injury to young children who might not be able to stop the bicycles using handbrakes only.
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.
The bicycle helmets do not comply with the positional stability and retention system requirements of the U.S. CPSC federal safety standard for bicycle helmets. The helmets can fail to protect in the event of a crash, posing a risk of head injury.