A broken fuse inside the laser that was caused by a short circuit at PIN 4 of the DOOR CTRL. This short circuit was caused by a badly positioned cable that made contact with the housing/frame and caused a short circuit and destroyed the fuse in the laser. This caused the shutter to remain in its most recent state; either in an open or closed position. Once the fuse was destroyed the shutter could not be operated.
If temperature management system fails to reach correct target water temperature while device is operating in patient control mode, due to sudden patient temperature changes/interruption in water flow/blockage of air flow by an obstruction or dirty filter, then system may not alert, and alarm absence may lead to hypothermia or hyperthermia, so a software update will be released to correct issue.
If blood culture identification panel is used in conjunction with specific lots of culture media bottles, then false positive Serratia marcescens results may occur, due to an increased level of non-viable organism from serratia marcescens targets in culture media bottles, false positive result may lead to an inappropriate change in patient therapy.
Some lots of Capio SLIM do not consistently catch the suture after activation possibly resulting in a prolonged procedure or additional medical intervention.
Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however the inner pouch label may contain information for a different model (catheter length)
Some lots of Capio SLIM do not consistently catch the suture after activation possibly resulting in a prolonged procedure or additional medical intervention.
The recalled light-up jelly ring toys violate the mandatory federal battery-operated toy regulation because the rings contain button cell batteries that fit within CPSC's small parts cylinder, and can be easily accessed without requiring the use of a common household tool. When button cell batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns and death, posing an ingestion hazard to children.
The recalled bassinets violate federal safety regulations for Infant Sleep Products because they do not have a stand, posing a fall hazard if used on elevated surfaces.
A loss of alignment between the handlebar and front wheel, due to insufficient torquing of steerer clamp bolts, can cause the rider to lose control of the steering, posing a fall hazard
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 federal safety regulations for Infant Sleep Products and the Safe Sleep for Babies Act. The swings also violate other requirements for infant swings and the labeling requirements for Reese's Law because the remote contains a button or coin-cell battery.
The youth ATVs fail to comply with the requirements of the federal mandatory ATV safety standard. The handlebars pose a laceration hazard if the child rider's body or head impacts the handlebars at a high rate of speed. Additionally, the parking brakes fail to hold, posing a collision hazard. The ATVs are also missing the required safety reflectors for vehicles intended for use by children 10 years and older. The 518 CY125ATV-6 model's footguards pose a laceration, contusion, and amputation hazard if the rider's foot enters the rear wheel environment. ATVs that fail to meet these mandatory safety requirements pose a risk of serious injury or death.