Life Pulse High Frequency Ventilator (HFV)
FDA device recall Z-0893-06 · posted 2006-05-23 · Terminated
Recall details
- Recalling firm
- Bunnell, Inc.
- 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.
- Action taken
- Notified consignees by letter on 04/04/2005.
- Root cause
- Other
- Status
- Terminated
- Product code
- LSZ
- Quantity affected
- 297 units
- Distribution
- Nationwide, Military medical center, Canada, and Czech Republic
- Date initiated
- 2005-04-04
- Date posted
- 2006-05-23
- Date terminated
- 2007-11-27
- Location
- Salt Lake City, UT
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