Date Initiated by Firm | October 25, 2010 |
Date Posted | January 14, 2011 |
Recall Status1 |
Terminated 3 on April 17, 2012 |
Recall Number | Z-0902-2011 |
Recall Event ID |
57377 |
PMA Number | P850064 |
Product Classification |
High Frequency Ventilator - Product Code LSZ
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Product | One Cat. Life Pulse High Frequency Ventilator, Catalog Number: 203, Manufactured by: Bunnell Incorporated Salt Lake City, Utah, Rx Only. |
Code Information |
Model 203 |
Recalling Firm/ Manufacturer |
Bunnell, Inc. 436 Lawndale Dr Salt Lake City UT 84115-2917
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For Additional Information Contact | Diane M. Goodman 801-467-0800 |
Manufacturer Reason for Recall | Product software coding error may compromise patient safety. |
FDA Determined Cause 2 | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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PMA Database | PMAs with Product Code = LSZ
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