FDA: Class I recall of Perseus A500 Anesthesia Workstation

Editor's Note

The Food and Drug Administration, on December 23, 2015, classified the recall of the Perseus A500 Anesthesia Workstation by Draeger as Class I, the most serious.

Draeger Medical (Telford, Pennsylvania) recalled the workstation because a faulty power switch may fail, causing the workstation to alarm and shut down unexpectedly.

If this occurs, ventilation may fail and the patient may not receive anesthesia or enough oxygen, leading to serious adverse health consequences, including injury or death.

The company has received one report of this issue occurring, with no injuries or deaths.

Posted 12/23/2015] AUDIENCE: Surgery, Anesthesiology, Risk Manager, Biomedical Engineering, Critical care medicine ISSUE: Draeger is recalling the Perseus A500 anesthesia workstation because a faulty power switch may fail, causing the workstation to alarm and shut down unexpectedly. If this occurs, ventilation may fail and the patient may not receive either anesthesia or enough oxygen.