One Cat. Life Pulse High Frequency Ventilator, Catalog Number: 203A, Manufactured by: Bunnell Incorporated Salt Lake City, Utah, Rx Only.
This recall has been terminated (originally issued January 14, 2011).
- Company
- Bunnell, Inc.
- Recall Initiated
- October 25, 2010
- Posted
- January 14, 2011
- Terminated
- April 17, 2012
- Recall Number
- Z-0901-2011
- Quantity
- 660 total
- Firm Location
- Salt Lake City, UT
- Official Source
- View on FDA website ↗
Reason for Recall
Product software coding error may compromise patient safety.
Distribution
Worldwide Distribution -- USA, Australia, Canada, Czech Republic, Korea, Malaysia, Trinidad & Tobago, and Uruguay.
Lot / Code Info
Model 203A
Root Cause
Software design
Action Taken
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.