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U.S. Department of Health and Human Services

Class 2 Device Recall Life Pulse High Frequency Ventilator

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  Class 2 Device Recall Life Pulse High Frequency Ventilator see related information
Date Initiated by Firm October 25, 2010
Date Posted January 14, 2011
Recall Status1 Terminated 3 on April 17, 2012
Recall Number Z-0901-2011
Recall Event ID 57377
PMA Number P850064 
Product Classification High Frequency Ventilator - Product Code LSZ
Product One Cat. Life Pulse High Frequency Ventilator, Catalog Number: 203A, Manufactured by: Bunnell Incorporated Salt Lake City, Utah, Rx Only.
Code Information Model 203A
Recalling Firm/
Manufacturer		 Bunnell, Inc.
436 Lawndale Dr
Salt Lake City UT 84115-2917
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
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.
PMA Database PMAs with Product Code = LSZ and Original Applicant = BUNNELL, INC.
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