A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reported with the applicable QC results if the statistical criteria is met. This may result in acceptance of QC results that do not meet acceptance criteria, which may cause erroneous patient results to be reported.
For some MRI systems, it has been found that some of the maximum Spatial Field Gradient (SFG) values displayed in "System Information" of the operation window and some of the maximum SFG values described in the safety manual are lower than the correct values, which may cause a patient with an MR conditional device to feel some discomfort during the MR scan.
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reported with the applicable QC results if the statistical criteria is met. This may result in acceptance of QC results that do not meet acceptance criteria, which may cause erroneous patient results to be reported.
The recalled crib mattresses violate the federal safety regulation for mattresses by failing to meet the flammability and labeling requirements, posing a fire hazard to children.
The clasp on the braided black bracelet sold as part of the gift set contains high levels of lead and cadmium. Lead and cadmium are toxic and can cause adverse health effects in children.
CPSC testing determined the magnetic ball sets do not comply with the requirements of the mandatory federal toy regulation because they contain one or more magnets that fit within CPSC's small parts cylinder and the magnets are stronger than permitted. When high-powered magnets are swallowed, the ingested magnets can attract each other, or 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 recalled 5mm magnetic ball sets violate the mandatory federal toy magnet regulation because they contain one or more magnets that fit within CPSC's small parts cylinder, and the magnets are stronger than permitted. When high-powered magnets are swallowed, the ingested magnets can attract each other, or 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 swings pose a suffocation risk because they were marketed, intended, or designed for infant sleep, and they have an incline angle greater than 10 degrees in violation of the CPSC's Infant Sleep Products Regulation and the Safe Sleep for Babies Act. In addition, the swing fails to meet mandatory warning requirements regarding sleep under the swing standard.
The recalled high chair, which converts into a booster seat, violates the safety regulations for both high chairs and booster seats. Multiple failures were identified including, but not limited to, insufficient restraint system, stability, static load, latching and locking mechanisms, leg openings, warnings, labels, and literature. The product can tip over or collapse and present a fall hazard to children.
A crack can occur between the PA-10 AC Power Adapter's upper and lower cases. The upper and lower cases can separate completely and expose electrical wiring, posing electrical shock and electrocution hazards to consumer.