Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and neonatal patients. Catalog Number: 8416400
Reported: October 20, 2021 Initiated: September 10, 2021 #Z-0108-2022
Product Description
Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and neonatal patients. Catalog Number: 8416400
Reason for Recall
Software 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
Details
- Recalling Firm
- Draeger Medical, Inc.
- Units Affected
- 6,797 units
- Distribution
- US Nationwide
- Location
- Telford, PA
Frequently Asked Questions
What product was recalled? ▼
Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and neonatal patients. Catalog Number: 8416400. Recalled by Draeger Medical, Inc.. Units affected: 6,797 units.
Why was this product recalled? ▼
Software 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 20, 2021. Severity: Moderate. Recall number: Z-0108-2022.
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