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U.S. Department of Health and Human Services

Class 1 Device Recall Respironics BiPAP Focus Noninvasive Ventilator System

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  Class 1 Device Recall Respironics BiPAP Focus Noninvasive Ventilator System see related information
Date Initiated by Firm September 22, 2008
Date Posted July 07, 2009
Recall Status1 Terminated 3 on July 06, 2010
Recall Number Z-1606-2009
Recall Event ID 52016
510(K)Number K053168  
Product Classification Ventilator, continuous, non-life-supporting - Product Code MNS
Product Respironics BiPAP Focus Noninvasive Ventilator System.

The BiPAP Focus is a non-invasive, pressure support ventilator used to augment the breathing of patients suffering from acute or chronic respiratory insufficiency, respiratory failure or to maintain airway patency and provide respiratory support to patients who experience obstructive sleep apnea. Nasal and full face masks are used with this device. The BiPAP Focus is intended for use in acute, sub-acute and intra-hospital transport settings.
Code Information Model Numbers: 8-400169-00, 7-400076-00, 8-400179-00, 8-400258-00, 8-400259-00, 8-400260-00, 8-400261-00 and 8-400216-00.
Recalling Firm/
Manufacturer		 Respironics California Inc
2271 Cosmos Ct
Carlsbad CA 92011-1517
For Additional Information Contact
760-918-7300
Manufacturer Reason
for Recall		 Power Supply failures have occurred on some ventilators. A discrepancy between the power supply strain relief clip and the power cord connector may allow unwanted movement of the cord and the unit's power supply. A disconnection or intermittent electrical connection between the power cord and the unit's power supply during operation or charging can result in transient power surges, which may cau
FDA Determined
Cause 2		 Component design/selection
Action Respironics California, Inc. issued an "Attention - Medical Device Field Correction" letter addressed to the Customer/Distributor dated September 22, 2008. The letter informed consignees of the affected device and instructions for removal, device replacement and return of the Business Response form by fax to 1-760-918-0169. Further question may be addressed to Respironics US Customer Service at 1-9800-345-6443 extension 5 or Respironics International Customer Service at 1-724-387-4000.
Quantity in Commerce 2,270 Power Cords
Distribution Worldwide to Argentina, Australia, Belgium, Brazil, Cambodia, Canada, Colombia, Denmark, Ecuador, Egypt, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Libya, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Portugal, Puerto Rico, Russian Fed., Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, United States and Venezuela.
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.
510(K) Database 510(K)s with Product Code = MNS and Original Applicant = RESPIRONICS (IRELAND) LIMITED
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