Recall Z-0901-2011 ยท LSZ Ventilator, High Frequency
Bunnell, Inc.
One Cat. Life Pulse High Frequency Ventilator, Catalog Number: 203A, Manufactured by: Bunnell Incorporated Salt Lake City, Utah, Rx Only.
| Date | Jan 14, 2011 (initiated Oct 25, 2010) |
| Status | Terminated |
| Reason | Product software coding error may compromise patient safety. |
| Root cause | Software design |
| Action | Customers were notified by an "Urgent: Medical Device Recall or Correction" letter starting 10/22/10. The letter identified the product and described the issues. Customers were given the option of either returning their ventilator(s) for rework or to receive installation/re-test instructions with an upgrade kit to rework themselves. The letter states that all Life Pulse ventilators in clinical use must be upgraded and there is no charge for the software upgrade. |
| Quantity | 660 total |
| Distribution | Worldwide Distribution -- USA, Australia, Canada, Czech Republic, Korea, Malaysia, Trinidad & Tobago, and Uruguay. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.