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Terminated

One Cat. Life Pulse High Frequency Ventilator, Catalog Number: 203, Manufactured by: Bunnell Incorporated Salt Lake City, Utah, Rx Only.

FDA Recall Z-0902-2011 · Posted 2011-01-14

Recalling FirmBunnell, Inc.
Recall StatusTerminated
Product CodeLSZ
Date Initiated2010-10-25
Date Terminated2012-04-17
Product Quantity660 total

Reason for Recall

Product software coding error may compromise patient safety.

Firm 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.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution -- USA, Australia, Canada, Czech Republic, Korea, Malaysia, Trinidad & Tobago, and Uruguay.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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