Life Pulse High Frequency Ventilator (HFV)
This recall has been terminated (originally issued May 23, 2006).
- Company
- Bunnell, Inc.
- Recall Initiated
- April 4, 2005
- Posted
- May 23, 2006
- Terminated
- November 27, 2007
- Recall Number
- Z-0893-06
- Quantity
- 297 units
- Firm Location
- Salt Lake City, UT
- Official Source
- View on FDA website ↗
Reason for Recall
Potential loss of air flow or change in cycling of the ventilator. Valve Drive Regulator Board may not function properly at elevated temperatures. The increase in temperature could cause a reduction of power, causing the solenoid in the valve to function sporadically.
Distribution
Nationwide, Military medical center, Canada, and Czech Republic
Lot / Code Info
Serial numbers 2585 and below.
Root Cause
Other
Action Taken
Notified consignees by letter on 04/04/2005.
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