Evita V500 Ventilator with Installed CO2 Measurement recall: Software Issue
Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and neonatal patients. Catalog Number…
Why was Evita V500 Ventilator with Installed CO2 Measurement 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
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Software 2.51 and Lower
- Product
- Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and neonatal patients. Catalog Number…
- Recalling firm
- Draeger Medical, Inc.
- Quantity
- 6,797 units
- Distribution
- US Nationwide
- Recall date
- October 20, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)