BEUDAMED
    FDA Enforcement Class II Ongoing

    Respironics RP-Touch Screen, V60/V680 Ventilator Serviced with Touchscreen RP Kit 453561511951 containing a touchscreen labeled as raw part number 1132318 Revision C

    Recall: Z-1154-2020 · Reported February 19, 2020

    Enforcement

    Recall Number
    Z-1154-2020
    Event ID
    83980
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Respironics California, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    February 19, 2020
    Initiation Date
    September 11, 2019
    Classification Date
    February 12, 2020
    Address
    2271 Cosmos Ct, Carlsbad, CA, 92011-1517, United States

    Description

    Respironics RP-Touch Screen, V60/V680 Ventilator Serviced with Touchscreen RP Kit 453561511951 containing a touchscreen labeled as raw part number 1132318 Revision C

    Reason

    Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requires a change in therapy, there is no warning associated with an unresponsive touchcreen, and therefore the clinician would have no prior indication of a touchscreen failure and would be unable to change ventilator settings. The ventilator will continue to function at the predetermined and accepted settings required to support the patient. A delay in therapy adjustments may result in hypercarbia and/or hypoxemia.

    Code Info

    Touchscreen Serial Number: 41088-1808-0001 to 0179, 41213-1809-0001 to 0200, 41305-1811-0001 to 0295, 41379-1812-0001 to 0250, 41379-1812-0251 to 0328, 41540-1813-0001 to 0195, 41633-1814-0001 to 0275, 41633-1814-0276 to 0285, 41724-1815-0001 to 0140, 41724-1815-0141 to 0183, 41838-1816-0001 to 0107, 41838-1816-0108 to 0165, 41930-1817-0001 to 0092, 42059-1818-0001 to 0150, 42059-1818-0151 to 0183, 42161-1819-0001 to 0117, 42161-1819-0118 to 0137, 42232-1820-0001 to 0130, 42232-1820-0131 to 0146, 42334-1822-0001 to 0134, 42334-1822-0135 to 0141, 42471-1823-0001 to 0143, 42471-1823-0144 to 0175, 42805-1828-0001 to 0138

    Distribution

    US Nationwide. OUS (Foreign): Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Finland, France, Germany, Greece, Hong Kong, Iceland, India, Indonesia, Israel, Italy, Malaysia, Mexico, Netherlands, Portugal, Singapore, South Africa, Spain, Sweden, United Arab Emirates, United Kingdom, Viet Nam, Oman, Philippines, Saudi Arabia, Taiwan, Turkey, Russian Federation, Argentina, Ecuador, Poland, Guatemala, Peru, Viet Nam

    Quantity

    800