This category includes all life-support devices, key resuscitation devices, and other devices whose failure or misuse is reasonably likely to result in serious injury to patients or staff. Any device that has been associated with serious injury in the past (either repeatedly or by nature of its design, but not simply because of an isolated incident) should be included unless a modified device design has greatly reduced the risk. Many of the items in this category are therapeutic equipment capable of delivering substantial energy. Examples include electrosurgical units (ESUs) and lasers, which can cause unintended burns; resuscitators, which, if not functional, could result in death; and heart-lung bypass units