Evita V500 Ventilator Software Defect May Cause Temporary Ventilation Loss
Draeger's Evita V500 ventilator software version 2.51 and lower may restart unexpectedly, briefly stopping ventilation and breathing support. 6,797 units are affected nationwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall involving a software defect that may cause temporary loss of mechanical ventilation support. No illnesses or injuries are reported in the source material, classifying this as a risk-of-harm scenario without documented patient incidents.
Plain-English summary
The Evita V500 ventilator, manufactured by Draeger Medical, is used to support breathing in adult, pediatric, and neonatal patients. A software defect in versions 2.51 and lower with the installed CO2 measurement option may cause the ventilator to restart unexpectedly.
When a restart occurs, the ventilator briefly stops providing ventilation and loses PEEP (positive end-expiratory pressure) for approximately 8 seconds. This interruption in breathing support poses a risk to patients who depend on mechanical ventilation.
Approximately 6,797 units have been distributed nationwide. The defect is associated with specific software versions and affects models with the CO2 measurement option installed.
Healthcare facilities using affected units should verify their software version and contact Draeger Medical for guidance on available patches or firmware updates to resolve this issue.
The recalled product
- Product
- Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and neonatal patients. Catalog Number: 8416400
- Manufacturer
- Draeger Medical, Inc.
- Affected units
- 6,797
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Software 2.51 and Lower
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Draeger Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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