BEUDAMED
    FDA Recall Open, Classified

    HAMILTON HEATER SHAKER, 115 VAC/ 230 VAC, 750 VA, Power Consumption 41V/ 100W (max.), Relative Humidity 15% - 85% no condensation. REF 19903400

    Recall: Z-1156-2021 · Initiated January 15, 2021

    Recall

    Recall Number
    Z-1156-2021
    Event Number
    87219
    Firm
    Hamilton Co
    FEI Number
    2915796
    Product Code
    JQW
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    January 15, 2021
    Address
    4970 Energy Way, Reno, NV, 89502-4123

    Description

    HAMILTON HEATER SHAKER, 115 VAC/ 230 VAC, 750 VA, Power Consumption 41V/ 100W (max.), Relative Humidity 15% - 85% no condensation. REF 19903400

    Reason

    There is a risk that the device can start a fire if flammable liquids contact and enter the device.

    Action

    An URGENT: MEDICAL DEVICE CORRECTION notifications was sent to the consignees via email of 01/15/2021. Hamilton Heater Shaker upgrades were started on 15-JAN- 2021. A device upgrade has been developed to mitigate the risk of the device catching fire. The upgrade consists of a plastic tray within the body of the Hamilton Heater Shaker and a redesigned base plate. These upgrades prevent liquid from reaching the electrical components of the device. The recall notification states: " Hamilton Company Field Service will contact your organization to schedule a time to upgrade your Hamilton Heater Shaker(s) to mitigate this risk. For customers who perform their own field service, a zero-dollar purchase order can be submitted to RoboticsOEMsales@hamiltoncompany .com to obtain upgrade kits. The upgrade consists of a plastic tray within the body of the Hamilton Heater Shaker and a redesigned base plate. These upgrades prevent liquid from reaching the electrical components of the device. This upgrade will be supplied free-of-charge and does not impact the functionality of the device. Until the upgrade is performed, it is crucial to observe the following safety best practices: o Methods should include labware touch-off presence checks to ensure the labware is ready to receive liquid. o On-deck waste and fluid collection devices should be placed at least one track away from Hamilton Heater Shakers or any other heating device. Recipients of this notice shall forward it to all customers to whom they have sold Hamilton Heater Shakers. Please complete and return the attached Acknowledgement and Receipt Form to [email protected] . On this form, please indicate if you have experienced a fire on your device. If you experience a fire on your device in the future, please notify your Hamilton representative immediately and cease using the device. Please contact [email protected] or call 800-527-5269 between 7:00am and 3:30pm P

    Distribution

    US - AL, AR, AZ, CA, CO, CT, DC. DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA. MD, ME. MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI AND WY OUS - AUSTRALIA, AUSTRIA, BRAZIL , CANADA , CHILE, CHINA, , COLOMBIA , FINLAND , GERMANY , ITALY , JAPAN , JPN , KOREA, SOUTH, PARAGUAY , PERU , PHL , ROMANIA , ROU , SINGAPORE, SWITZERLAND , SWITZERLAND , THAILAND, TWN , UNITED KINGDOM, AND URUGUAY

    Quantity

    4729 units