Firm has identified Drug Library Management defects in the software: 1) DLM software does not allow user to create percentage dose rate or rate change values with certain limits, potentially resulting in over-delivery to patient. 2) An unauthorized user may modify and approve a drug library, potentially leading to incorrect program parameters being used for therapy.
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during use.
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection can result in severe consequences for neonates, including hypoxia, hypercapnia, and organ failure.
The high chairs pose a deadly fall hazard to babies because the restraint system is not attached to the product and the locks or latches can fail. In addition, the high chairs pose an entrapment hazard because the opening between the seat and tray is large enough that a child can become entrapped in it. These are violations of the federal regulations for high chairs.
The recalled children's pajama sets violate flammability standards for children's sleepwear, posing a burn hazard and risk of serious injuries or death to children.
The recalled child safety gates violate the federal safety regulation for expansion gates and expandable enclosures because a child's torso can fit through the opening between the gate slat and side wall, a child's torso can fit through the secondary opening, the locking mechanism does not fully engage and/or the gate does not resist a push-out force. These failures pose a risk of serious injury or death due to entrapment and fall hazards.
The recalled rollers tile toy violates the mandatory federal regulation for toy magnets because it contains a magnet that can become loose, posing an ingestion hazard to children. When high-powered magnets are swallowed, the ingested magnets can attract each other, or other metal objects, and become lodged in the digestive system. This can result in perforations, twisting, and/or blockage of the intestines, infection, blood poisoning, and death.