FDA Medical Device Recalls (openFDA)
Bunnell, Inc.: Life Pulse High Frequency Ventilator (HFV)
- Recall number
- Z-0893-06
- Recalling firm
- Bunnell, Inc.
- Product
- Life Pulse High Frequency Ventilator (HFV)
- Status
- Terminated
- Initiated
- 2005-04-04
- Posted
- 2006-05-23
- Terminated
- 2007-11-27
- Reason
- 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.
- Root cause
- Other
- Action
- Notified consignees by letter on 04/04/2005.
- Quantity
- 297 units
- Distribution
- Nationwide, Military medical center, Canada, and Czech Republic
- Lot, serial or model codes
- Serial numbers 2585 and below.
- 510(k) numbers
- not on file
- PMA numbers
- ["P850064"]
- Product code
- LSZ
- Firm FEI
- 3032745446
- Firm city
- Salt Lake City
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28