On April 25, Draeger, Inc. recalled Perseus A500 Anesthesia System for risk of sudden unexpected shutdown when used on battery power. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
The number of devices recalled in the U.S. is 3,713 and the devices were distributed from December 12, 2011 to February 29, 2024.
The Perseus A500 anesthesia workstation is intended for use in anesthetizing adults, children, and neonates and can be used for automatic and manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing.
Draeger Inc. is recalling the Perseus A500 anesthesia workstation after receiving reports that the internal backup battery failed spontaneously while the system was being operated off the main power supply. The battery failure caused unexpected shutdown without a low battery alarm while the device was running on battery power.
If the Perseus shuts down suddenly, patients may not receive enough ventilation (hypoventilation) or enough oxygen (hypoxia) while an alternative form of ventilation is initiated. Use of this device may cause serious injury or death.
Draeger Inc. reports four incidents related to this issue. There have been no reported injuries or deaths.
