Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal patients Catalog Number: 8416400
Reported: April 13, 2022 Initiated: February 14, 2022 #Z-0870-2022
Product Description
Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal patients Catalog Number: 8416400
Reason for Recall
Cybersecurity Improvement Action-not equipped against potential cyber security threats
Details
- Recalling Firm
- Draeger Medical, Inc.
- Units Affected
- 24,337 (10,728 units US)
- Distribution
- US Nationwide
- Location
- Telford, PA
Frequently Asked Questions
What product was recalled? ▼
Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal patients Catalog Number: 8416400. Recalled by Draeger Medical, Inc.. Units affected: 24,337 (10,728 units US).
Why was this product recalled? ▼
Cybersecurity Improvement Action-not equipped against potential cyber security threats
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 13, 2022. Severity: Moderate. Recall number: Z-0870-2022.
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