Recall Z-0893-06 ยท LSZ Ventilator, High Frequency
Bunnell, Inc.
Life Pulse High Frequency Ventilator (HFV)
| Date | May 23, 2006 (initiated Apr 4, 2005) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.