BEUDAMED
    FDA Recall Terminated

    Blanketrol III Data Export Software Version 1.10 The Blanketrol III Data Export Software is intended for use in the electronic transfer of medical device data from the Blanketrol III to a computer, without controlling or altering the function or parameters of the Blanketrol III.

    Recall: Z-0443-2014 · Initiated May 15, 2013

    Recall

    Recall Number
    Z-0443-2014
    Event Number
    66632
    Firm
    Cincinnati Sub-Zero Products Inc
    FEI Number
    1516825
    Product Code
    DWJ
    Status
    Terminated
    Root Cause
    Software Manufacturing/Software Deployment
    Initiated
    May 15, 2013
    Posted
    December 4, 2013
    Terminated
    May 13, 2014
    Address
    12011 Mosteller Rd, Cincinnati, OH, 45241-1528

    Description

    Blanketrol III Data Export Software Version 1.10 The Blanketrol III Data Export Software is intended for use in the electronic transfer of medical device data from the Blanketrol III to a computer, without controlling or altering the function or parameters of the Blanketrol III.

    Reason

    During a customer inquiry regarding a beta version of the Bill Data Export Software, Model USB-127, it was discovered that the wrong software version was released to a customer.

    Action

    Cincinnati Sub-Zero sent a Urgent Medical Device Notification letter dated July 15, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. They instructed their customers to to do the following: 1) Upon receipt of the corrected Blanketrol III Data Export Software disc, immediately collect and destroy all previous Blanketrol III Data Export Software disc from this lot # currently in possession and replace all downloaded Blanketrol III Data Export Software with the correct version provided by CSZ. 2) After the Blanketrol Data Export Software Version 1.00 have been destroyed and downloaded versions replaced with version 1.10, complete and return the enclosed response form as soon as possible to acknowledge receipt of this notification and to inform CSZ that you have performed and completed the requested actions. Return the form by fax to (513) 772-9119 scan and e-mail the information to [email protected], or mail to: Cincinnati Sub-Zero 12011 Mosteller Road Cincinnati, OH 45241 U.S.A. For further questions please call 1-(800) 989-7373 or (513) 772-8810.

    Distribution

    Worldwide Distribution - US Distribution including the following states AK, CO, FL, MA, MI, and NC. and Internationally to Canada, Germany and United Kingdom.

    Quantity

    12 Units