BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-1606-2009 · Initiated September 22, 2008

    Recall

    Recall Number
    Z-1606-2009
    Event Number
    52016
    Firm
    Respironics California Inc
    FEI Number
    2518422
    Product Code
    MNS
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    September 22, 2008
    Posted
    July 7, 2009
    Terminated
    July 6, 2010
    Address
    2271 Cosmos Ct, Carlsbad, CA, 92011-1517

    Description

    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.

    Reason

    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

    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.

    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.

    Quantity

    2,270 Power Cords