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Terminated

Life Pulse High Frequency Ventilator (HFV)

FDA Recall Z-0893-06 · Posted 2006-05-23

Recalling FirmBunnell, Inc.
Recall StatusTerminated
Product CodeLSZ
Date Initiated2005-04-04
Date Terminated2007-11-27
Product Quantity297 units

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.

Firm Action

Notified consignees by letter on 04/04/2005.

Root Cause

Other

Distribution Pattern

Nationwide, Military medical center, Canada, and Czech Republic

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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