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.
Recalled Product
- Product Name: Perseus A500
- Product Codes: See Recall Database Entry
- Devices Recalled in the U.S.: 3,713
- Dates Distributed: December 12, 2011 to February 29, 2024
- Date Initiated by Firm: March 10, 2024
Device Use
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.
Perseus is equipped with airway monitoring, gas measurement and device monitoring, oxygen blower (insufflation), and an anesthetic gas receiving system. The device creates anesthesia by mixing pure oxygen and medical compressed air or pure oxygen and nitrous oxide along with anesthetic agents. Ventilation is provided to the patient through a laryngeal mask, a breathing mask, or an endotracheal tube.
Perseus is intended to be used for inhaled anesthesia, patient ventilation, or both during surgical or diagnostic procedures.
Reason for Recall
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.
Who May Be Affected
- People who may receive anesthesia using the Perseus A500.
- Health care providers who provide anesthesia during procedures using the Perseus A500.
What to Do
On March 10, 2024, Draeger Inc. issued an Urgent Medical Device Recall Notice that recommended customers perform the following actions:
- Perform a test of all device batteries.
- Return all devices that failed the battery test.
- Complete the Verification Form included with the letter, even if there is no product to return.
Contact Information
Customers with questions should contact Michael A. Kelhart, Director of Quality by email [email protected] or phone 267-664-1131.
