Product Safety Recalls

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Draeger Medical, Inc. Recall 88635

Description: Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and neonatal patients. Catalog Number: 8416400

Draeger Medical, Inc. Recall 88635 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0108-2022
Event ID88635
Event DescriptionEvita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and neonatal patients. Catalog Number: 8416400
Product TypeDevices
DistributionUS Nationwide
Quantity6,797 units
Recall ReasonSoftware 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief cessation of ventilation can occur and loss of PEEP for approx. 8 seconds
Device Classification20211020
Device Code InfoSoftware 2.51 and Lower
Center Classification Date20211013
Recall Initiation Date20210910
Recalling FirmDraeger Medical, Inc.
Initial Notification Letter
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