Recall Z-0360-2016— Draeger Medical, Inc.
Class I · Terminated
Class I FDA medical device recall by Draeger Medical, Inc., initiated 2015-11-12, terminated 2017-04-05. It names one FDA 510(k) clearance: K133886. 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.. Reason: 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..
- Recalling firm
- Draeger Medical, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2015-11-12
- Terminated
- 2017-04-05
- Firm location
- Telford, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.