Evita 4 Critical Care Ventilator. Continuous (Respirator)
This recall has been terminated (originally issued September 20, 2008).
- Company
- Draeger Medical, Inc.
- Recall Initiated
- July 2, 2008
- Posted
- September 20, 2008
- Terminated
- September 1, 2009
- Recall Number
- Z-2326-2008
- Quantity
- 83 units
- Firm Location
- Telford, PA
- Official Source
- View on FDA website ↗
Reason for Recall
audible power failure alarm was not enunciated at the required volume
Distribution
The products were shipped to medical facilities in AZ, CA, CO, FL, GA, IL, KY, MA, MI, MS, NJ, NY, PA, TN, TX, UT and WA.
Lot / Code Info
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.
Root Cause
Nonconforming Material/Component
Action Taken
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.
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