Draeger Medical, Inc. Evita 4 Critical Care Ventilator. Continuous (Respirator) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Evita 4 Critical Care Ventilator. Continuous (Respirator)
Brand
Draeger Medical, Inc.
Lot Codes / Batch Numbers
ARX, or ARY.
Products Sold
Catalog number 8411900. Products recalled had the CO2 Carrier Printed Circuit Board (PCB) part number 8306611 replaced between January 2005 and May 2008. The serial number for the affected CO2 Carrier PCBs have a prefix of ARW, ARX, or ARY.
Draeger Medical, Inc. is recalling Evita 4 Critical Care Ventilator. Continuous (Respirator) due to audible power failure alarm was not enunciated at the required volume. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
audible power failure alarm was not enunciated at the required volume
Recommended Action
Per FDA guidance
The recalling firm issued an URGENT MEDICAL DEVICE RECALL letter dated 7/2/08 informing the consignees of the problem and the need to have the circuit board replaced.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, CO, FL, GA, IL, IN, KY, MA, MI, MS, NJ, NY, PA, TN, TX, UT, WA
Page updated: Jan 10, 2026