Evita V500 Ventilator with Software 2.51.01 and Lower recall
Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal patients Catalog Number: 8416400
Why was Evita V500 Ventilator with Software 2.51.01 and Lower recalled?
Cybersecurity Improvement Action-not equipped against potential cyber security threats
What should I do if I have this product?
Review the official FDA enforcement record for current 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?
All Lots/Serial Numbers. UDI: 04048675042266
- Product
- Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal patients Catalog Number: 8416400
- Recalling firm
- Draeger Medical, Inc.
- Quantity
- 24,337 (10,728 units US)
- Distribution
- US Nationwide
- Recall date
- April 13, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)