Critical care ventilators recalled for software defects affecting alarm and operation
Draeger Medical is recalling critical care ventilators due to software defects that can cause the device to restart, display incorrect oxygen alarms, and suspend weaning protocols. No patient injuries have been reported.
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: This is an FDA Class II recall of a critical care ventilator with software defects affecting vital monitoring and respiratory support functions. Although no patient injuries have been reported, the product poses a risk of harm; incorrect alarms and unexpected restarts could compromise patient care in life-critical situations.
Plain-English summary
Draeger Medical, Inc. is recalling critical care ventilators due to three software-related defects. The recall affects the Evita V600 (Catalog Number 8422300) and includes related models Evita V800, Babylog VN600, and Babylog VN800.
The software defects can cause unexpected restarts during ventilation operation, incorrect oxygen level alarms (FiO2 high and FiO2 low), and inappropriate suspension of the SmartCare/PS weaning protocol.
The recalled units, numbering 34 units total, were distributed across Pennsylvania, Texas, Maryland, Florida, Washington, Mississippi, and New York. Affected devices have serial numbers manufactured between January 1, 2019, and March 31, 2021.
Healthcare facilities using affected ventilators should contact Draeger Medical or their equipment supplier to arrange corrective action. No patient injuries have been reported in connection with these defects.
The recalled product
- Product
- Critical Care Ventilator, Catalog Number(s): 8422300: Evita V600 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons.
- Manufacturer
- Draeger Medical, Inc.
- Affected units
- 34
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)
- All lots/serial numbers manufactured from 1/1/2019-3/31201
Distribution
Part of a larger recall action
This product is one of 4 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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