FDA-Device2015-12-23Class I
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.
Draeger Medical, Inc.
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.
Sold states
US Distribution -- To the states of WI, PA, OH, ME, IL, and NY.
Affected count
34
Manufactured in
3135 Quarry Rd, N/A, Telford, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0360-2016Don't want to check this manually?
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