FDA Medical Device Recalls (openFDA)
Bunnell, Inc.: One Cat. Life Pulse High Frequency Ventilator, Catalog Number: 203A, Manufactured by: Bunnell Incorporated Salt Lake City, Utah, Rx Only.
- Recall number
- Z-0901-2011
- Recalling firm
- Bunnell, Inc.
- Product
- One Cat. Life Pulse High Frequency Ventilator, Catalog Number: 203A, Manufactured by: Bunnell Incorporated Salt Lake City, Utah, Rx Only.
- Status
- Terminated
- Initiated
- 2010-10-25
- Posted
- 2011-01-14
- Terminated
- 2012-04-17
- 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.
- Lot, serial or model codes
- Model 203A
- 510(k) numbers
- not on file
- PMA numbers
- ["P850064"]
- Product code
- LSZ
- Firm FEI
- 3032745446
- Firm city
- Salt Lake City
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28