BEUDAMED
    FDA Enforcement Class II Ongoing

    Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel, for the attended or unattended monitoring of single or multiple vital signs in clinical and pre hospital care applications. The affected power supplies are related to the following Tempus Pro Patient Monitoring units: Model Numbers: 00-1004 00-1004-R 00-1007 00-1007-R 00-1024-R 00-1026-R Model Numbers: 00-1004 00-1004-R 00-1007 00-1007-R 00-1024-R 00-1026-R

    Recall: Z-1321-2023 · Reported April 12, 2023

    Enforcement

    Recall Number
    Z-1321-2023
    Event ID
    91805
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Remote Diagnostic Technologies Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 12, 2023
    Initiation Date
    February 23, 2023
    Classification Date
    March 31, 2023
    Address
    Farnborough Aerospace Centre, Aerospace Boulevard, Farnborough, N/A, United Kingdom

    Description

    Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel, for the attended or unattended monitoring of single or multiple vital signs in clinical and pre hospital care applications. The affected power supplies are related to the following Tempus Pro Patient Monitoring units: Model Numbers: 00-1004 00-1004-R 00-1007 00-1007-R 00-1024-R 00-1026-R Model Numbers: 00-1004 00-1004-R 00-1007 00-1007-R 00-1024-R 00-1026-R

    Reason

    During internal testing, Regulatory Compliance issues were identified regarding the Monitor and Power Supplies for fluid ingress and basic safety issues.

    Code Info

    Model Numbers: 00-1004 00-1004-R UDI-DI Codes: 05060472440020 05060472442901 00-1007 00-1007-R UDI-DI Codes: 05060472440013 05060472442901 00-1024-R UDI-DI Codes: 05060472441027 05060472442925 00-1026-R UDI-DI Codes: 05060472441058 05060472442932 Lot Codes - All products manufactured are affected.

    Distribution

    Worldwide Distribution: U.S.(nationwide): AL, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI, WV, WY and O.U.S.(foreign): United Arab Emirates, Afghanistan, Austria, Australia, Belgium, Brunei Darussalam, Bolivia, Canada, Switzerland, Czechia, Germany, Denmark, Spain, France, United Kingdom, Hong Kong, Ireland, Israel, Iceland, Italy, Cayman Islands, Luxembourg, Malaysia, Netherlands, Norway, Portugal, Romania, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, Mayotte, and South Africa.

    Quantity

    5,540 units