Z-0901-2011

One Cat. Life Pulse High Frequency Ventilator, Catalog Number: 203A, Manufactured by: Bunnell Incorporated...

Name: Z-0901-2011 One Cat. Life Pulse High Frequency Ventilator, Catalog Number: 203A, Manufactured by: Bunnell Incorporated...
Creator: Bunnell, Inc.
Published: 2010-10-25
License: https://open.fda.gov/license/

Cutler Campus / initiated 2010-10-25 / Terminated / root cause: software

FDA source

Bunnell, Inc. began a recall of One Cat. Life Pulse High Frequency Ventilator, Catalog Number: 203A, Manufactured by: Bunnell Incorporated Salt Lake City, Utah, Rx Only on 2010-10-25. The reason FDA records is "Product software coding error may compromise patient safety". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0901-2011
Status: Terminated
Initiated: 2010-10-25
Posted: 2011-01-14
Terminated: 2012-04-17
Recalling firm: Cutler Campus
Product: One Cat. Life Pulse High Frequency Ventilator, Catalog Number: 203A, Manufactured by: Bunnell Incorporated Salt Lake City, Utah, Rx Only.
Product code: LSZ Ventilator, High Frequency
Reason for recall: Product software coding error may compromise patient safety.
Root cause tag: software
FDA 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 in commerce: 660 total
Distribution: Worldwide Distribution -- USA, Australia, Canada, Czech Republic, Korea, Malaysia, Trinidad & Tobago, and Uruguay.
Product codes and lots: Model 203A

Product code LSZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)