Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and neonatal
Summary
The FDA issued a Class II for Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ven by Draeger Medical, Inc.. Reason: Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief cessation of ventilation can occur and .
Details
Source
Device Recall
External ID
Z-0108-2022
Action Date
2021-10-20
Status
Ongoing
Category
device
Product Description
Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and neonatal patients. Catalog Number: 8416400
Lot/Code Info: Software 2.51 and Lower
Quantity Affected: 6,797 units
Reason for Recall
Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief cessation of ventilation can occur and loss of PEEP for approx. 8 seconds
Distribution
US Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2021-09-10
Company
Telford, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 174 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Draeger Medical, Inc. has 37 FDA actions in our database, including 37 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Draeger Medical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Draeger Medical, Inc. have FDA actions?
Draeger Medical, Inc. has 37 FDA actions in our database, including 37 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0108-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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