Reported Apr 13, 2022 · Terminated
Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal…
Draeger Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Draeger Medical, Inc. · 3135 Quarry Rd · Telford, PA · 18969-1042
Is this the product you have?
- Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric
- and neonatal patients Catalog Number8416400
- Lot codes and dates
- All Lots/Serial Numbers
- UDI04048675042266
- Amount recalled
- 24,337 (10,728 units US)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Cybersecurity Improvement Action-not equipped against potential cyber security threats
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Draeger Medical, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.