Reported Dec 23, 2015 · Terminated

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

Draeger Medical, Inc.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Draeger Medical, Inc. · 3135 Quarry Rd · Telford, PA · 18969-1042

Is this the product you have?

  • 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.
Lot codes and dates
    • ASHB-0140
    • ASHF-0039
    • ASHF-0055
    • ASHF-0056
    • ASHF-0057
    • ASHH-0008
    • ASHH-0009
    • ASHH-0010
    • ASHH-0011
    • ASHH-0012
    • ASHH-0013
    • ASHH-0014
    • ASHJ-0095
    • ASHJ-0096
    • ASHJ-0097
    • ASHJ-0098
    • ASHJ-0099
    • ASHK-0001
    • ASHK-0002
    • ASHK-0003
    • ASHK-0008
    • ASHK-0009
    • ASHK-0010
    • ASHK-0056
    • ASHK-0057
    • ASHK-0079
    • ASHK-0080
    • ASHK-0081
    • ASHK-0082
    • ASHK-oo83
    • ASHK-0084
    • ASHK-0085
    ASHK-0086, and ASHK-0087.
Amount recalled
34

Where it was sold

Why it was recalled

Stop using this product now

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.

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 5, 2017 · Data as of Sep 19, 5:21 PM UTC

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