Other Medical Devices

A software bug affecting results when using deep learning (DL) segmentation followed by geometrical functions: Create wall function, Expand Contract function or ROI algebra function, the results are incorrect. If dose statistics for an incorrectly created ROI are used to determine if a plan is acceptable for treatment, this could potentially lead to an inappropriate plan being approved. The error could lead to a more conservative or more liberal plan than intended.

Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

Firm has received reports of patient burns in surgical procedures where device was used.

Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.