BEUDAMED
    FDA Recall Terminated

    External power supply adaptors that accompany Clinitek Status+ The Clinitek Status systems is a urine analyzer.

    Recall: Z-0081-2015 · Initiated September 19, 2014

    Recall

    Recall Number
    Z-0081-2015
    Event Number
    69228
    Firm
    Siemens Healthcare Diagnostics, Inc
    FEI Number
    1219913
    Product Code
    JIL
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 19, 2014
    Posted
    October 17, 2014
    Terminated
    July 20, 2015
    Address
    333 Coney St, East Walpole, MA, 02032-1516

    Description

    External power supply adaptors that accompany Clinitek Status+ The Clinitek Status systems is a urine analyzer.

    Reason

    The external power supply for the Clintek Status analyzer, which is provided separately, is damaged. It can result in an electric shock to the User.

    Action

    Siemens sent an Urgent Field Safety Notice dated September 2014, to all by e-mail to all affected Siemens Healthcare Diagnostics Regional offices on September 19, 2014 both in the United States and elsewhere for communication with affected customers. This notice informs customers of the issue with the power supply and the potentially affected products that may contain a damaged power supply. Consignees are asked to complete a Field Correction Effectiveness Check form and return in to Siemens Healthcare Diagnostics via Fax to (312) 275-7795. All affected domestic customers were sent a hard copy of the Urgent Field Safety Notice via Federal Express on 9/23/14. All affected customers outside the US will be provided a copy of an Urgent Field Safety Notice via hard copy, e-mail, and/or fax as determined by each countries local regulations and procedures. Customers with questions were instructed to contact their local Siemens technical support representative. For questions regarding this recall call 877-229-3711.

    Distribution

    Worldwide Distribution - USA (nationwide) including Puerto Rico and Internationally Canada, Mexico, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Great Britain, Greece, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Kuwait, Latvia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Qatar, Republic Korea, Romania, Russian Fed., Saudi Arabia, Senegal, Singapore, Slovakia, Slovenia, South Africa, Sweden, Switzerland, Tadjikistan, Taiwan, Turkey, Turkmenistan, Unit.Arab Emir., United Kingdom, Vietnam.

    Quantity

    approx. 4200