Z-0893-06

Life Pulse High Frequency Ventilator (HFV)

Name: Z-0893-06 Life Pulse High Frequency Ventilator (HFV)
Creator: Bunnell, Inc.
Published: 2005-04-04
License: https://open.fda.gov/license/

Cutler Campus / initiated 2005-04-04 / Terminated

FDA source

Bunnell, Inc. began a recall of Life Pulse High Frequency Ventilator (HFV) on 2005-04-04. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0893-06
Status: Terminated
Initiated: 2005-04-04
Posted: 2006-05-23
Terminated: 2007-11-27
Recalling firm: Cutler Campus
Product: Life Pulse High Frequency Ventilator (HFV)
Product code: LSZ Ventilator, High Frequency
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.
FDA root cause: Other
Action: Notified consignees by letter on 04/04/2005.
Quantity in commerce: 297 units
Distribution: Nationwide, Military medical center, Canada, and Czech Republic
Product codes and lots: Serial numbers 2585 and below.

Product code LSZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)