Draeger has recalled 3,713 Perseus A500 anesthesia workstations following reports that the internal backup battery had failed spontaneously while the system was being operated off the main power supply.
The devices, distributed between Dec. 12, 2011, and Feb. 29, 2024, are under a Class I recall — the most serious FDA-issued recall.
The 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, according to an April 25 FDA alert.
If the Perseus shuts down suddenly, patients may not receive enough ventilation or enough oxygen, causing serious injury or death.
Draeger has reported four incidents related to this issue, but no injuries or deaths.