Consumer Product Recalls

Hazard: Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.

Hazard: Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.

Hazard: Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.

Hazard: Treatment reagent functionality in respiratory specimens fluidification cannot be guaranteed.

Hazard: Treatment reagent functionality in respiratory specimens liquification cannot be guaranteed.

Hazard: Software intended to aid in diagnosing conditions, planning treatments, visualizing anatomical structures has a bug that, if all of following are met: Viewing images in InteleShare viewer; Multiplanar reconstruction applied; Manual rotation applied, could result in inaccurate length measurement tool values that could compromise diagnostic accuracy, lead to misdiagnosis or inappropriate follow-up.

Hazard: Following a component change in the DPOAE probe (speaker replacement), technical distortions may occur at high stimulus levels combined with unusually low OAE amplitude acceptance thresholds. These distortions can mimic true DPOAE responses and may result in a false PASS outcome.

Hazard: Recalled lots were manufactured with double the amount of preservative concentration.

Hazard: The NorthStar OCT Navigation Surgical Technique Guide (STG) incorrectly identified both Medtronic s Solera and Medtronic s Infinity system toolcards as compatible with the NorthStar OCT Navigation Instruments. However, the NorthStar OCT Navigation Instruments are compatible for use with Medtronic s Solera toolcards only.

Hazard: Several software anomalies with the potential to impact patient treatment, of which one includes the possibility to result in treatment stop if certain conditions are fulfilled.

Hazard: GE HealthCare has become aware that the Patient History tab in ViewPoint 6 versions 6.15.3 and 6.15.4 ultrasound software may not include complete patient medical history information.

Hazard: The IFU addendum updates the Vibration and Shock Table to reference the correct standards.

Hazard: The IFU addendum updates the Vibration and Shock Table to reference the correct standards.

Hazard: Potential for incomplete seal on header bag.

Hazard: Potential for incomplete seal on header bag.

Hazard: Potential for incomplete seal on header bag.

Hazard: Potential for incomplete seal on header bag.

Hazard: Potential for incomplete seal on header bag.

Hazard: The devices may have a misaligned thickness control bar.

Hazard: The devices may have a misaligned thickness control bar.

Hazard: The items may have weak packaging seals that may result in a breach of sterility if the seal fails and may lead to an increased risk of infection if product is utilized.

Hazard: The items may have weak packaging seals that may result in a breach of sterility if the seal fails and may lead to an increased risk of infection if product is utilized.

Hazard: When the Worstation of the BeneVision DMS has a specific hardware configuration, the computer may experience audio playback failure or screen freezing.

Hazard: Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure. Anesthesia systems only operate on battery power in a rare event that AC mains power is lost and there is no continuous backup emergency power. If AC power is interrupted, the system will not automatically switch over to the battery supply mode and will reboot. If this issue occurs, a temporary disruption of mechanical ventilation, manual ventilation, and volatile agent delivery may occur. Following the reboot, the system will not return to the previous ventilation settings.

Hazard: Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure. Anesthesia systems only operate on battery power in a rare event that AC mains power is lost and there is no continuous backup emergency power. If AC power is interrupted, the system will not automatically switch over to the battery supply mode and will reboot. If this issue occurs, a temporary disruption of mechanical ventilation, manual ventilation, and volatile agent delivery may occur. Following the reboot, the system will not return to the previous ventilation settings.

Hazard: Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure. Anesthesia systems only operate on battery power in a rare event that AC mains power is lost and there is no continuous backup emergency power. If AC power is interrupted, the system will not automatically switch over to the battery supply mode and will reboot. If this issue occurs, a temporary disruption of mechanical ventilation, manual ventilation, and volatile agent delivery may occur. Following the reboot, the system will not return to the previous ventilation settings.

Hazard: Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.

Hazard: Undeclared Milk and FD&C Blue #1.

Hazard: possible salmonella

Hazard: Potential contamination with Salmonella.