Draeger Medical, Inc. recalls Perseus A500 Anesthesia Workstation, MK06000. Intended for use in anesthetizing adults, children, and neonates and can…

Recall date

November 12, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0360-2016

FDA classification

Class I

Brand / firm

Draeger Medical, Inc.

Sold / distributed

US Distribution -- To the states of WI, PA, OH, ME, IL, and NY.

Why it was recalled

There is a potential problem with the device main power switch of the Perseus A500 Anesthesia Workstation. The device power switch may spontaneously fail during use, causing one of the following to occur: 1. The workstation has a fresh gas delivery failure and a ventilator failure with respective alarms. 2. The workstation shuts down completely with an audible alarm.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Perseus A500 Anesthesia Workstation, MK06000. 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.