BEUDAMED
    FDA Enforcement Class II Terminated

    Panda Freestanding Warmer. Device sold under the following product names: Panda Freestanding Warmer and Panda Freestanding Warmer Generic ATO Model. Infant Radiant warmer.

    Recall: Z-0483-2019 · Reported November 28, 2018

    Enforcement

    Recall Number
    Z-0483-2019
    Event ID
    81224
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    GE Healthcare, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 28, 2018
    Initiation Date
    September 25, 2018
    Classification Date
    November 19, 2018
    Termination Date
    July 13, 2020
    Address
    3000 N Grandview Blvd, N/A, Waukesha, WI, 53188-1615, United States

    Description

    Panda Freestanding Warmer. Device sold under the following product names: Panda Freestanding Warmer and Panda Freestanding Warmer Generic ATO Model. Infant Radiant warmer.

    Reason

    Potential electric leakage affecting the user.

    Code Info

    Model Number, UDI (Serial Number): 2063568-001-535551, 010084068210391621PFSX7006711180626 (PFSX70067); 2063568-001-289325, Not Applicable (HDJT51400); 2063568-001-289325, Not Applicable (HDJT51401); 2063568-001-528373, 010084068210391621PFSX7005911180618 (PFSX70059); 2063568-001-529111, 010084068210391621PFSX7008111180731 (PFSX70081); 2063568-001-501555, 010084068210391621PFSV6011411161219 (PFSV60114); 2063568-001-562946, 010084068210391621PFSX7005011180503 (PFSX70050); 2063568-001-297793, Not Applicable (HDJT51542); 2063568-001-533799, 010084068210391621PFSW60069170515 (PFSW60069); 2063568-001-347865, Not Applicable (HDJT61189); 2063568-001-533888, 010084068210391621PFSW6007111170515 (PFSW60071); 2063568-001-533888, 010084068210391621PFSW6007011170515 (PFSW60070); 2063568-001-533888, 010084068210391621PFSW6007211170515 (PFSW60072);

    Distribution

    Worldwide distribution. US Nationwide, Algeria, Australia, Austria, Belgium, Canada, Chile, China, Costa Rica, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Honduras, India, Indonesia, Ireland, Italy, Japan, Kazakhstan, Korea, Lithuania, Mexico, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam.

    Quantity

    1,724 devices total