One Cat. Life Pulse High Frequency Ventilator, Catalog Number: 203A, Manufactured by: Bunnell Incorporated Salt Lake Cit
FDA device recall Z-0901-2011 · posted 2011-01-14 · Terminated
Recall details
- Recalling firm
- Bunnell, Inc.
- Reason for recall
- Product software coding error may compromise patient safety.
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LSZ
- Quantity affected
- 660 total
- Distribution
- Worldwide Distribution -- USA, Australia, Canada, Czech Republic, Korea, Malaysia, Trinidad & Tobago, and Uruguay.
- Date initiated
- 2010-10-25
- Date posted
- 2011-01-14
- Date terminated
- 2012-04-17
- Location
- Salt Lake City, UT
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