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Draeger Medical, Inc. recalls Perseus A500 Anesthesia Workstation, MK06000. Intended for use in anesthetizing adults, children, and neonates and ca
Recalled December 23, 2015 · FDA recall Z-0360-2016 · Draeger Medical
Hazard
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. · FDA Class I
Units
34
Sold at
US Distribution -- To the states of WI, PA, OH, ME, IL, and NY.
Description
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.
Product
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.
Manufacturer(s)
Draeger Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →